BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 4140493 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17285
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    May 17, 2014
    Report Date
    September 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    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. THE COMPLETE LEAD WAS RETURNED SEVERED IN TWO SEGMENTS. SET SCREW MARK WAS NOTED ON ALL TERMINAL CONNECTORS. ONE OF THE TESTS BEING DONE REVEALED THAT THE INNER INSULATION HIPOT TEST REVEALED INNER INSULATION WAS DAMAGED. DAMAGED WAS CONSISTENT WITH LONG PIN IS-1 TERMINAL CONNECTOR DAMAGE. THE FIELD ALLEGATIONS WERE CONFIRMED AND THAT THE LEAD WAS CLINICALLY OUT OF SPECIFICATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS GOING TO UNDERGO A GASTRIC BYPASS PROCEDURE WHEN IT WAS OBSERVED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED THRESHOLD MEASUREMENTS AND NOISE WHICH WAS OVERSENSED AND RESULTED IN AN INAPPROPRIATE SHOCK. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED TROUBLESHOOTING OPTIONS TO THE CALLER. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618855 ENDOTAK DSP IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR T167| 1810| 4269| 1861| 0125| E143| 1853