BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1840204 · Received September 21, 2010

    Report

    Report Number
    2124215-2010-18494
    Event Type
    Death
    Date Received
    September 21, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION CONFIRMED SET SCREW MARKS IN THE IS-1 TERMINAL PIN AND RING. RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT TESTING WERE WITHIN NORMAL LIMITS. EVIDENCE REVEALED THE TRILUMEN INSULATION WAS FOUND TO BE TORN, CUT AND PUNCTURED ON BOTH SIDES, AND THE RS (-) COIL WAS KINKED. THIS DAMAGE WAS MOST LIKELY DUE TO A TYPE OF GRASPING TOOL DURING THE EXPLANT PROCEDURE. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS PRODUCT WAS INVOLVED IN A CAR ACCIDENT THAT CAUSED THE PATIENT TO PASS AWAY. FOLLOWING THE ACCIDENT, IT WAS QUESTIONED IF THERE WAS A CARDIAC EVENT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ACCIDENT. IT WAS ALSO NOTED THAT THIS PACEMAKER HAD A DEFIBRILLATOR RIGHT VENTRICULAR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death 4513| 0158| H125