BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1874012 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18572
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION NOTED A CUT IN THE INSULATION BETWEEN THE ELECTRODE TIP UNIT AND DISTAL FITTING AS WELL AS A CUT THROUGH PTFE FOR RATE/SENSE NEGATIVE COIL. THE RATE/SENSE NEGATIVE COIL WAS EXPOSED. THE DAMAGE APPEARS TO BE INDUCED. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. THE ALLEGATION OF HIGH PACING IMPEDANCES ONE DAY POST IMPLANT WAS NOT CONFIRMED BY ANALYSIS. RESISTANCE TESTS CONFIRMED THE LEAD'S CONDUCTIVE PATHS TO BE IN SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD WAS EXPLANTED, HAVING ONLY BEEN IMPLANTED ONE DAY DUE TO HIGH OUT OF RANGE PACING IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention