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CorePace Module 9 - Pacemaker Troubleshooting

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					Pacemaker Troubleshooting
         Module 9




                            1
Objectives

• List steps in performing troubleshooting
• Correctly identify the following on an ECG strip:
  – Pacemaker ERI behavior
  – Loss of Capture
  – Over- and undersensing
  – Magnet behavior
  – Pseudo-malfunctions
• Make clinically appropriate suggestions based on
  interpretation
  – Identify additional information or other resources useful to
    diagnosing pacemaker malfunction


                                                                   2
Some Good Advice

• Perform all troubleshooting and all pacemaker checks the
  same way
  – Collect the data
  – Ask questions
  – Keep an open mind
  – Analyze, form hypothesis, test
  – Don‟t make assumptions

• The simplest explanation that covers all the facts, is usually
  the correct explanation




                                                                   3
The Four Solutions to Pacemaker Problems

• Re-Program – the device
• Re-Place – the system or a component
• Re-Position – the lead(s), the device
• Retreat – do nothing, because nothing is wrong




                                                   4
The Process

• Observe/collect data
  – Measure the ECG (e.g., A-A, V-V, A-V, V-A)

• Form your hypothesis
• Test your “solution”
• Make a suggestion
  – Ask the clinician questions




                                                 5
Data Sources

• Programmed parameters    • Device model number
• Patient symptoms         • Lead model numbers
• Medical history          • Telemetry data
• Indication for implant     – Impedances

• Implant date               – Battery voltage
                             – Marker Channel™
• Rhythm strip
                           • Device diagnostics
                           • Device RRT and EOS behaviors




                                                            6
Case 1

• Information you have:
   – DDD 60-130                            Click for Hint
   – PAV/SAV 150-120 ms
   – PVARP 310 ms




• Question: Why is rhythm irregular, sometimes fast?
   – Hypotheses:
     • Tracking PAF
     • Oversensing (tracking a “P-wave” that is not there)
     • Are these grouped beats – upper tracking rate behavior?



                                                                 7
Case 1
First Hypothesis: Tracking Paroxysmal AF


• What is the evidence for AF?
  – Irregular ventricular events
  – Could be “fine” AF, not visible on baseline

• What is the evidence against AF?
  – Some visible P-waves
  – Evidence of atrial pacing




                                                  8
Case 1
Second Hypothesis: Atrial Oversensing


• What is the evidence for atrial oversensing?
  – Irregular ventricular tracking
  – Evidence of ventricular tracking without visible P-waves


• What is evidence against atrial oversensing?
  – There may be P-waves “hidden” in some T-waves




                                                               9
Case 1
Third Hypothesis: Upper Rate Behavior


• What is the evidence for Wenckebach?
  – Some evidence of “grouped” beats
  – Evidence of P-waves “hidden” in some T-waves

• What is evidence against Wenckebach?
  – The A-A intervals don‟t march out
  – Evidence of atrial pacing – no need if this is UTR behavior




                                                                  10
Case 1
What Are Your Next Steps?


• To form a better hypothesis:
  – Interrogate pacemaker
  – Observe ECG and Marker Channel strip

• To test the hypothesis:
  – Perform sensing test – observe rhythm/markers
  – Check lead impedance for low impedance (insulation break), which
    often causes oversensing (< about 250 Ω)
     • What is the normal impedance range (assume standard leads)?




                                                                       11
Case 1
Final Hypothesis: Arial Oversensing


• Confirmed by
  – Marker Channel annotations showing AS markers without P-waves




                                                                    12
Case 1
Conclusion: Arial Oversensing


• What do you consider?
  – The “service” you provide to the customer is not in just interpreting
    pacemaker behavior
  – You are there to supplement the customer‟s clinical knowledge and
    experience with your knowledge and experience regarding the
    pacing system
  – If the customer asks, you have to be ready to make an appropriate
    suggestion
     • Ask questions
     • Find out the relevant concerns that the customer has for this patient
     • If you are uncertain, call Technical Services




                                                                               13
Example Case 1
Conclusion: Arial Oversensing

• Cause
  – Insulation breach
  – Bipolar impedance: 190 Ω




                                14
Example Case 1
Conclusion: Artial Oversensing

• Considerations:
  – How easy is it to “fix”
     • Unipolar lead in situ

  – What are the risks to the patient to “fix”
     • Elderly, debilitated patient

  – What are the risks/implications if it is not “fixed”
     • Loss of AV synchrony
     • Possible that AF diagnostics are not accurate
     • Risk of PMT

  – Are there any alternatives?
     • VVI?




                                                           15
Example Case 1
Conclusion: Arial Oversensing

• Cause
  – Unknown

• Other resources
  – Medtronic Technical Services
     • 1 800 505 4636 (within the U.S.)

  – Medtronic Product Performance Report
     • There may be an issue with a particular Medtronic product you
       are not aware of
     • Other manufacturers do not necessarily produce these reports

  – Your colleagues

                                                                       16
Case 2

• Programming information:
  – DDD 60–130 bpm
  – PAV: 150 ms
  – SAV: 120 ms
  – PVARP: 310 ms




                             17
Case 2
Hypothesis

Loss of Capture                                              Click for Answer
  – Idioventricular rate is masquerading as a “capture/pseudo-fusion”




                                                              Click for Answer
  To test hypothesis:
       - Perform a threshold test




                                                                                 18
Case 2
Considerations

• Causes                                • Considerations
  – If there were changes in              – Program a higher output for an
    medications, or an MI, or the           increased safety margin, as
    patient had renal failure, etc. ?       conditions are changing

  – If chronic lead impedance is          – Suspect fracture. Could try
    high?                                   unipolar temporarily, but this will
                                            likely require a lead
                                            replacement.
  – If lead impedance is ok?              – Suspect dislodgement. Can try
                                            a higher output, but permanent
                                            fix will likely be repositioning.

  – If acute lead impedance is high?      – Likely a loose set screw. Need
                                            to re-open the pocket and
                                            retighten it.
  Click for Answers


                                                                                  19
Case 3

• Programming information
  – DDD 60–120 bpm
  – PAV: 150 ms
  – SAV: 120 ms
  – PVARP: 380 ms




                            20
Case 3
Hypothesis: Pacemaker Wenckebach

• Upper rate behavior                                            Click for Answer
   – Is this evidence of “grouped beats?”
   – Do we see regular atrial activity with increasing A-V intervals?
• Intermittent atrial undersensing
   – Do the pauses occur because a P-wave is not sensed, and thus,
     not tracked?




                                                                                    21
Case 3
Hypothesis: Pacemaker Wenckebach


• How do you test this hypothesis?                            Click for Answer

  – Knowing what the patient was doing when this occurred is helpful.
    For example, this strip was collected while the patient was on a
    treadmill (exercising).
  – Analyze the strip:
     • The regularity of the increasing A-V intervals is obvious
     • The regularity of the grouped beats is suggestive

  – What other hypotheses are there? For example, intermittent atrial
    undersensing might look like this – test for these as well.
  – If possible, recreate the conditions
  – Finally, what is TARP? What are the atrial intervals? Is pacemaker
    Wenckebach possible?

                                                                                 22
Case 3
Hypothesis: Pacemaker Wenckebach

• Considerations                                                 Click for Answer
  – Is this really a problem?
     • The pacemaker is behaving normally
  – What to consider if the patient‟s ADL‟s are compromised?
     • Pacer Wenckebach occurs when the atrial rate increases and approaches the 2:1
       block point
     • Recall from the Timing Modules that (SAV + PVARP) = TARP, so we:

         – Can increase the UTR
         – And decrease TARP by:
            » Less PVARP
            » Less AV – use Rate Adaptive AV
            » Use Auto-PVARP options


                                                                                       23
Case 4

• Your information:
  – DDD 60–130 bpm
  – PAV: 150 ms
  – SAV: 120 ms
  – PVARP: 310 ms




                      24
Case 4
Hypothesis


• What explains this atrial pace?                             Click for Answer
  – Intermittent atrial undersensing. The P-wave was not “seen”
    and the lower rate (LRL) timed out, resulting in an atrial pace




• Review question:                                       Click for Answer
  – Why did this atrial pace NOT capture? (Hint: Think of the
    ECG module.)
     • Because the atrial pacing occurred in the absolute refractory
       period of the atrial muscle tissue



                                                                                 25
Case 4
Confirming Your Hypothesis


• What would you do?         • Interrogate and observe
                               the rhythm

• What would you expect to   • P-waves without markers
  see?

       Click for Answers




                                                         26
Case 4
Testing Your Hypothesis


• What would you do to test   • Perform a sensing test
  your hypothesis?              – Is the device programmed
                                  correctly?
                                – P/R- wave amplitudes can
      Click for Answers           change

                              • Check Lead Impedances
                                – Undersensing can be a symptom
                                  of a lead fracture or lead
                                  insulation failure
                                – Undersensing can be a symptom
                                  of lead dislodgement




                                                                  27
Case 4
Considerations

• Suppose the device were            • 2.0 mV is more sensitive than
  programmed to 4.0 mV atrial          4.0 mV
  sensitivity, and the P-waves
  measure 4.0- 5.0 mV. Would
  programming a sensing value of
  2.0 mV make it more or less
                                             Click for Answers
  sensitive?


• Would you choose 2.0 mV or a
  value even more sensitive if the   • Program to a more sensitive
  device operations remained           value to make sure the device
  normal? Why?                         can sense AF, for example




                                                                       28
One Consequence of Atrial Undersensing

• Programming information:
  – DDD 60–120 bpm
  – PAC: 150 ms
  – SAV: 120 ms
  – PVARP: 310 ms




• PMT (pacemaker mediated tachycardia) caused by atrial
  undersensing and retrograde conduction
• The abrupt onset is one hallmark of PMT

                                                          29
PMT
Pacemaker Mediated Tachycardia


• Occurrence minimized with introduction of Auto-PVARP or
  dynamic TARP operations
  – Which provide longer pacemaker atrial refractory periods at lower
    rates

• PMT is similar to a re-entrant tachycardia discussed in
  Module 1
  – Except the pacemaker forms part of the re-entrant circuit




                                                                        30
PMT Mechanism

                • A ventricular event occurs
                   – Paced or sensed – we show a PVC
                     here
                • Conducts retrograde through the AV
                  node (typically)
                • And results in an atrial sense
                   – Which starts an SAV, and results in a
                     ventricular pace
                • This is again conducted retrograde,
                  and the sequence starts again
                   – VP, which goes retrograde V-A,
                     resulting in an AS starting an SAV,
                     resulting in a…VP which goes retrograde V-A
                     resulting in an AS starting an SAV resulting in a…
                     VP which goes retrograde V-A resulting in an AS starting an
                     SAV resulting in a… VP which goes retrograde V-A resulting in an AS
                     starting an SAV resulting in a…

                   – You get the idea


                                                                                           31
PMT Requirements

                   • For the sequence to be
                     maintained:
                     – The AV node and atrium must be
                       able to conduct retrograde, i.e.,
                       not be depolarized
                     – The pacemaker must be able to
                       sense this retrograde
                       depolarization, i.e., not be in a
                       refractory period
                     – This timing „ballet‟ must persist




                                                           32
Case 5
Hypotheses


• Is this PMT?                                 Click for Answers

• Is this simply the pacemaker tracking a sinus tachycardia?
  – DDD 60-120 PAC/SAV 150-120 ms, PVARP 310 ms




• What was the patient doing when this occurred?
• If exercising, it may favor tracking
• If at rest, be suspicious of PMT
                                                                   33
Case 5
Confirming Your Hypotheses
                                                   Click for Answers


• Place a magnet on the device          • A magnet makes the pacemaker
  during the tachycardia. What            DOO
  happens?


• If this is PMT, what would you        • PMT requires atrial sensing
  expect to see?                           – DOO suspends the pacemaker‟s
                                             sensing function, so the PMT
                                             breaks


• If this is tracking, what would you   • Evidence of atrial tachycardia
  expect to see?                          during asynchronous operation



                                                                            34
Case 5
Confirming Your Hypotheses

• Place a magnet on the device




• DOO suspends sensing and the tachycardia terminates
• No evidence of atrial tachycardia during the asynchronous
  operation


                                                              35
Case 5
Considerations

• The AV node and atrium must     • Typical causes
  be able to conduct retrograde
                                    – Loss of atrial capture
  (i.e., not be depolarized)
                                    – Loss of atrial sensing (atrial
                                      undersensing)
                                    – Atrial oversensing

• The pacemaker must be able        – PVC with retrograde
  to sense this retrograde            conduction/accessory pathway
  depolarization (i.e., atrial
  event falling outside of a      • Typical causes
  refractory period)
                                    – PVARP too short
                                    – Auto-PVARP not in use
                                    – PVC Response not in use



                                                                       36
Addressing PMT

• Test
  – Atrial output threshold
  – Atrial sensing test
  – Retrograde conduction
• To fix
  – Reprogram the pacemaker outputs as needed
  – Increase PVARP to make the retrograde atrial event an AR
     • Turn PMT Intervention “On”
     • Turn PVC Response “On”
  – Rarely, may need to reposition a lead or ablate a pathway



                                                                37
Solution: PVC Response

• Designed to prevent sensing of retrograde P-waves, when
  they happen due to a PVC




                                                            38
Solution: PMT Intervention

• Designed to interrupt a Pacemaker-Mediated Tachycardia




     DDD / 60 / 120

                                                           39
Case 6

• Programming information     Click for Hint

  – DDD 60–130 bpm
  – PAV: 150 ms
  – SAV: 120 ms
  – PVARP: 320 ms




• Any hypotheses?
  – Atrial undersensing
  – Ventricular oversensing


                                               40
Case 6
Hypothesis: Atrial Undersensing




                                X




• If this P-wave is not sensed, and not tracked, then determine when the
  next atrial event should occur in the timing sequence
• DDD 60 (1000 ms) minus the SAV (120 ms) = 880 ms from the last
  QRS to the next atrial pace (the V-A interval). We should see an atrial
  pace at the X.
• Thus, this cannot be atrial undersensing



                                                                            41
Case 6
Hypothesis: Ventricular Oversensing


• Remember the information                    – PVARP 320 ms
                                              – Calculated the V-A = 880 ms
   – A-A = 1000 ms
   – A-V = 120 ms



                                                           A
                                                           R

                                                     V
                                                     S
Measure the V-A interval from the atrial pace, and assume the pacemaker
sensed a ventricular “event” here.
The atrial event then fell in the PVARP of this “event” – and can not be used
for timing, thus it did not start an SAV.

                                                                                42
Case 6
Confirming the Hypothesis: Ventricular Oversensing

                                                     Click for Answers



• What would you do?              • Interrogate and observe the rhythm

                                  • VS/VR markers without QRS
• What would you expect to see?     complexes




                                                                         43
Case 6
Confirming the Hypothesis: Ventricular Oversensing


• But suppose you interrogate and consistently get this strip.
  What next?
                    Click for Answers   – Run a sensing test anyway
                                        – Try to provoke oversensing
                                        – Program to non-RR mode
                                          • Arm/shoulder movement
                                          • Have patient reach across
                                            his/her body
                                          • Observe Marker Channel for
                                            VS without a QRS
                                             – More common with
                                               unipolar sensing



                                                                         44
Review Questions
                                                  Click for Answers
• What patient complaints might you suspect with this strip?
• What pacemaker telemetry data might indicate the cause?
• What long-term effect will this condition have on device
  diagnostics?
                                 • C/O syncope, presyncope, vertigo,
                                   weakness…

                                 • Ventricular lead impedance

                                 • Ventricular rate diagnostics
                                   inaccurate because of this
                                   oversensing – may be interpreted
                                   as arrhythmia

                                                                       45
A Little Advice…

• When you see evidence of “over pacing” i.e., pacing
  despite intrinsic activity
  – Consider undersensing
  – See Case 4

• When you see evidence of “under-pacing” i.e., pauses
  without pacing
  – Consider oversensing
  – See Case 6

• These rules are NOT absolute



                                                         46
Case 7
No Programmer Available

Questions to ask yourself:                                Click for Hints
                                                         Click for Answers
• Is this a single chamber VVI pacemaker?
• If it is dual chamber, is it tracking?
  – But if it is tracking what would cause AV intervals to change?



• If it is not tracking, e.g.,            • Hard to believe this is
  because of atrial undersensing,           tracking with these AV
  what causes the V pacing?                 intervals, and it can‟t be
• Can‟t be VVI, see A-V pacing.             Wenckebach at this rate
  Must be dual-chamber device             • Good question!


                                                                             47
Case 7
No Programmer Available
                                                              Click for Answers

Questions to ask yourself:               • How about DDI(R)
• What kind of pacemaker:                  – The response to sensing is to
                                             inhibit
   – Paces in the atrium and ventricle
                                           – No SAV can be initiated
   – Senses in the atrium and
     ventricle                             – Without an AP, the ventricle is
                                             paced at the lower rate
   – But does NOT track?
                                           – If after a V-A interval, there is no
• The simplest answer that                   AS, then an AP and a PAV
  explains all the facts, is                           Click for Hints
  likely the correct answer.




                                                                                    48
Case 7
Review Questions

                                                        Click for Answers




• What is the underlying rhythm?   • It appears to be Complete Heart
                                     Block
                                      – No evidence of AV synchrony
• Is the pacing mode appropriate
  for this rhythm?                 • DDIR? No

• What would be a better choice?
                                   • DDD or even VDD
• Why?
                                   • It looks like the atrium is reliable


                                                                            49
Case 8
No Programmer Available


• Patient is in the hospital on bed rest
• Admitted for non-cardiac problem
  – Medical record indicates he has a dual chamber pacemaker




A physician hands you this and says, ”I think he is
having PMT, what is your opinion?”



                                                               50
Case 8
No Programmer Available: Hypotheses

• Is this PMT?                        • No, PMT requires tracking – this
                                        shows atrial pacing

• If not PMT, what would cause        • Atrial rate of about 100 bpm
  atrial pacing at this rate (which      – Could be Rate Reponse pacing
  is…?)
                                         – Or a special pacemaker intervention

• How can it be Rate Response –       • Rate Response could be
  he is at rest?                        programmed too aggressively. It
                                        might be an MV sensor, and he is
   Click for Answers                    having a fever or an anxiety attack…




                                                                             51
Case 8
No Programmer Available: Confirming the Hypothesis


• What resources are             • What information would
  available to you?                you look for?
                                   – Mode of pacemaker
  – Medical Record and Nurse
                                      • Patient vital signs/activity
  – Office pacemaker chart
                                   – Model
  – Technical Services
                                   – Last programmed values
  – Patient
                                   – Indication
                                   – Interpretation/Confirmation of
     Click for Answers
                                     the ECG strip
                                      • Other explanations

                                   – What were you doing?


                                                                       52
Case 9

• Programming                        • How can there be pacing and
  information                          sensing at less than the lower
                                       rate?
  – DDDR 60-130 bpm
  – PAV: 150 ms                      • Is this pacemaker
                                       malfunctioning?
  – SAV 120 ms
                            Atrial Rate Histogram
  – PVARP: Auto
  – No other therapies or
    unusual programming
    options chosen




                                                                        53
Case 9
Hypotheses


• Phenomena:
  – The device pace appears to be operating at less than the lower rate

• Hypotheses:
  – There are special programming options that could affect the
    histogram producing these results
    • Hysteresis
    • Sleep Function

  – The device is actually programmed to a lower rate of 40 bpm
  – The programming information is correct, so the device is
    malfunctioning



                                                                          54
Case 9
Why is the Pacemaker Altering the Lower Rate?


• Interrogation confirms:
  – Programming information is correct
  – DDDR 60-130 bpm, PAV/SAV 150/120 ms, PVARP-Auto
  – Hysteresis and Sleep Function: Off
                                                       Click for Hint

Recall from Module 7:
Normally, pacemakers use A-A timing to maintain a steady atrial rate.
V-V timing is used only under some special circumstances. This is an
example of the effect the change in fundamental timing has on the
pacemaker.




                                                                        55
Case 9

• Basic IPG timing is A-A, but after a (pacemaker-defined)
  PVC, it switches to V-V timing




                                            1600ms     DDDR 60/130

• This maintains a stable V-V interval (at the lower or sensor
  indicated rate, whichever is faster and depending on the
  mode)
• The resulting AS-AP interval may exceed LRL and is noted
  in the histogram

                                                                 56
Case 9
Considerations

• Is the pacemaker                  • No, this is normal pacemaker
  malfunctioning?                     behavior


• Is the patient symptomatic with   • Unlikely, as the ventricular rate is
  this pacemaker operation?           relatively stable


• What do you suggest?              • The pacemaker is implanted in
                                      order to address patient
                                      symptoms. Concentrate on the
       Click for Answers              patient, not on the diagnostic.




                                                                             57
Recap
The Four Solutions to Pacemaker Problems

• Re-Program – the device
• Re-Place – the system or a component
• Re-Position – the lead(s), the device
• Retreat – do nothing, because nothing is wrong

So….
• Observe/Collect data
• Measure (e.g., A-A, V-V, A-V, V-A)
• Form your hypothesis
• Test your “solution”
• Make a suggestion



                                                   58
Final Nugget

• Most pacemaker “malfunctions” can be explained by:
  – Dislodged leads or failing leads
  – Battery end-of-life
  – Inappropriate programming due to
     • Changing patient conditions
     • An error
  – Normal operations you do not fully understand
• Sudden changes in timing are almost always normal
  pacemaker (if advanced) operations




                                                       59
Brief Statements
Indications
•   Implantable Pulse Generators (IPGs) are indicated for rate adaptive pacing in patients who ay benefit from increased
    pacing rates concurrent with increases in activity and increases in activity and/or minute ventilation. Pacemakers are
    also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV
    synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration
    of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac
    output and VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent sinus rhythm.
•   Implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular
    defibrillation for automated treatment of life-threatening ventricular arrhythmias.
•   Cardiac Resynchronization Therapy (CRT) ICDs are indicated for ventricular antitachycardia pacing and ventricular
    defibrillation for automated treatment of life-threatening ventricular arrhythmias and for the reduction of the symptoms of
    moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite
    stable, optimal medical therapy and have a left ventricular ejection fraction less than or equal to 35% and a QRS
    duration of ≥130 ms.
•   CRT IPGs are indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class
    III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular
    ejection fraction less than or equal to 35% and a QRS duration of ≥130 ms.
Contraindications
•   IPGs and CRT IPGs are contraindicated for dual chamber atrial pacing in patients with chronic refractory atrial
    tachyarrhythmias; asynchronous pacing in the presence (or likelihood) of competitive paced and intrinsic rhythms;
    unipolar pacing for patients with an implanted cardioverter defibrillator because it may cause unwanted delivery or
    inhibition of ICD therapy; and certain IPGs are contraindicated for use with epicardial leads and with abdominal
    implantation.
•   ICDs and CRT ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or
    reversible causes, patients with incessant VT or VF, and for patients who have a unipolar pacemaker. ICDs are also
    contraindicated for patients whose primary disorder is bradyarrhythmia.




                                                                                                                                  60
Brief Statements (continued)
Warnings/Precautions
• Changes in a patient‟s disease and/or medications may alter the efficacy of the device‟s programmed
  parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid
  possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an
  arrhythmia, device electrical reset or device damage. Do not place transthoracic defibrillation paddles
  directly over the device. Additionally, for CRT ICDs and CRT IPGs, certain programming and device
  operations may not provide cardiac resynchronization. Also for CRT IPGs, Elective Replacement
  Indicator (ERI) results in the device switching to VVI pacing at 65 ppm. In this mode, patients may
  experience loss of cardiac resynchronization therapy and / or loss of AV synchrony. For this reason,
  the device should be replaced prior to ERI being set.
Potential complications
• Potential complications include, but are not limited to, rejection phenomena, erosion through the skin,
  muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, and
  surgical complications such as hematoma, infection, inflammation, and thrombosis. An additional
  complication for ICDs and CRT ICDs is the acceleration of ventricular tachycardia.
• See the device manual for detailed information regarding the implant procedure, indications,
  contraindications, warnings, precautions, and potential complications/adverse events. For further
  information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at
  www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.




                                                                                                            61
Brief Statement: Medtronic Leads
Indications
• Medtronic leads are used as part of a cardiac rhythm disease management system. Leads are
  intended for pacing and sensing and/or defibrillation. Defibrillation leads have application for patients
  for whom implantable cardioverter defibrillation is indicated
Contraindications
• Medtronic leads are contraindicated for the following:
• ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve.
• patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate or dexamethasone
  acetate may be contraindicated. (includes all leads which contain these steroids)
• Epicardial leads should not be used on patients with a heavily infracted or fibrotic myocardium.
• The SelectSecure Model 3830 Lead is also contraindicated for the following:
• patients for whom a single dose of 40.µg of beclomethasone dipropionate may be contraindicated.
• patients with obstructed or inadequate vasculature for intravenous catheterization.




                                                                                                              62
Brief Statement: Medtronic Leads (continued)
Warnings/Precautions
• People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and
  accompanying leads should not receive diathermy treatment. The interaction between the implant and
  diathermy can cause tissue damage, fibrillation, or damage to the device components, which could
  result in serious injury, loss of therapy, or the need to reprogram or replace the device.
• For the SelectSecure Model 3830 lead, total patient exposure to beclomethasone 17,21-dipropionate
  should be considered when implanting multiple leads. No drug interactions with inhaled
  beclomethasone 17,21-dipropionate have been described. Drug interactions of beclomethasone
  17,21-dipropionate with the Model 3830 lead have not been studied.
Potential Complications
• Potential complications include, but are not limited to, valve damage, fibrillation and other arrhythmias,
  thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade,
  muscle or nerve stimulation, pericardial rub, infection, myocardial irritability, and pneumothorax.
  Other potential complications related to the lead may include lead dislodgement, lead conductor
  fracture, insulation failure, threshold elevation or exit block.
• See specific device manual for detailed information regarding the implant procedure, indications,
  contraindications, warnings, precautions, and potential complications/adverse events. For further
  information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at
  www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.




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Disclosure

                               NOTE:
   This presentation is provided for general educational purposes
    only and should not be considered the exclusive source for this
         type of information. At all times, it is the professional
       responsibility of the practitioner to exercise independent
               clinical judgment in a particular situation.




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