Medtronic CRM Product Performance Report

Advisories

4004, 4004M CapSure Ventricular Lead
4082 Target Tip Ventricular Lead
Original Date of Advisory: October 8, 1993

Lead Survival Below Expectations

Product

All Model 4004/4004M and 4082 implantable pacing leads

Advisory

Lead survival probability is below expectations due primarily to polyurethane insulation failure (MIO) and conductor fracture (associated with “subclavian crush”).

Patient Management Recommendations

  • Increase, as appropriate, the frequency of patient evaluation through in-clinic visits supplemented with transtelephonic and/or ambulatory monitoring; for example, consistent with Guideline I under Medicare Pacemaker Monitoring Guidelines (50-1 Cardiac Pacemaker Evaluation Services)
  • During patient evaluations, give careful attention to lead performance such as:
    • – Reviewing patient ECGs carefully for indications of transient sensing and/or capture abnormalities
    • – Monitoring in-clinic for impedances less than 300 ohms or a decrease of more than 30% from implant values (or an established baseline using telemetry), which would suggest lead failure
    • – Eliciting and thoroughly investigating any patient complaints suggestive of lead failure
  • Consider whether prophylactic replacement would be appropriate, especially in patients at high risk, such as pacemaker dependent patients
  • Carefully evaluate lead integrity when performing routine pulse generator replacements. Replace lead if:
    • – Insulation breaches are observed
    • – Lead impedance is less than 300 ohms or has decreased by more than 30% from implant values
    • – Impedance or voltage threshold measurements vary significantly when multiple readings are taken
    • – If the risk of continued use outweighs the risk associated with implanting a new lead
  • As always, individual circumstances and medical judgment dictate patient care and frequency of follow-up
  • Consider lead replacement during normal pulse generator change-out. Carefully evaluate lead integrity and patient status before choosing to reuse.

Status

Patient management recommendations remain unchanged. Laboratory analysis trends and engineering conclusions remain unchanged. Out of the initial implant population of 77,000 in the United States, approximately 6,000 remain implanted. According to System Longevity Study results, lead survival is 50.6% at 10 years, 9 months.