BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3953792 · Received July 23, 2014

    Report

    Report Number
    2124215-2014-14298
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 12, 2014
    Report Date
    July 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS CONFIRMED THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. MICROSCOPIC INSPECTIONS FOUND THE DISTAL HIGH VOLTAGE CABLE WAS FRACTURED AT THE PROXIMAL SIDE OF THE YOKE STAKE BLOCK, CAUSING THE HIGH OUT OF RANGE MEASUREMENTS OBSERVED. THE DAMAGE TO THE LEAD WAS CONSISTENT WITH FORCE BEING APPLIED TO PULL THE LEAD AND THEN LETTING GO.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD WAS ATTEMPTED AT IMPLANT. HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED WHEN THIS LEAD WAS CONNECTED TO THE DEVICE. THIS LEAD WAS NOT USED AND A DIFFERENT LEAD WAS IMPLANTED. HIGH OUT OF RANGE MEASUREMENTS WERE AGAIN OBSERVED. A NEW DEVICE WAS USED WITH THE SECOND LEAD AND ACCEPTABLE MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431581 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0171

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR E141| 0171| E161