BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211574 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09338
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHRONIC IMPLANTABLE DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED. A NEW LEAD AND DEVICE WERE SUCCESSFULLY IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE REPLACEMENT, A REPLACEMENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED WITH THIS CHRONIC IMPLANTABLE DEFIBRILLATION LEAD. DURING DEFIBRILLATION THRESHOLD (DFT) TESTING, THE DEVICE DELIVERED A SHOCK AND A SHORT CIRCUIT WARNING MESSAGE WAS OBSERVED. THE PATIENT REQUIRED EXTERNAL DEFIBRILLATION. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). DURING DFT TESTING WITH THE NEW DEVICE, A SHORT CIRCUIT WARNING MESSAGE WAS AGAIN OBSERVED FOLLOWING SHOCK DELIVERY. ALL LEAD MEASUREMENTS WERE OBSERVED TO BE STABLE AND ACCEPTABLE, HOWEVER, A LEAD ISSUE WAS SUSPECTED. ONE OF THE DF PINS OR YOKE INSULATION WAS SUSPECTED TO BE WORN OUT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308783 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 0296| T135| E141| 0175| E051| E140