Medtronic CRM Product Performance Report

Advisories

4504, 4504M CapSure Atrial Lead
4582 Target Tip Atrial Lead
Original Date of Advisory: October 4, 1996

Lead Survival Below Expectations

Product

All Model 4504, 4504M, and 4582 implantable pacing leads

Advisory

Lead survival probability is below expectations and is primarily associated with insulation degradation due to Metal Ion Oxidation (MIO).

Patient Management Recommendations

  • Follow patients in accordance with Medicare Guidelines
  • Avoid the use of the AAI or AOO mode
  • During patient evaluation, give careful attention to lead performance such as:
    • – Review patient ECG for indications of transient sensing and/or capture abnormalities
    • – Monitor in clinic for impedance less than 250 ohms or a decrease of more than 30% from implant values (or an established baseline using telemetry), which would suggest lead failure
  • Consider the use of unipolar if the pulse generator has this capability
  • At the time of pacemaker system revision (e.g., normal pulse generator or ventricular lead revision), 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 16,600 in the United States, approximately 1,700 remain implanted. According to System Longevity Study results, lead survival is estimated to be 66.1% at 8 years, 9 months.