BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSI ICD

    MDR report key: 2143858 · Received June 23, 2011

    Report

    Report Number
    MW5021137
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC, INC.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH A 3 LEAD BOSTON SCIENTIFIC CRTD ON (B)(6), 2011. PT PRESENTED FOR F/U AND INTERROGATION OF THE DEVICE ON (B)(6), 2011. IT WAS NOTED THAT THE BATTERY CONSUMPTION WAS 285% OF EXPECTED. THE DEVICE WAS REPROGRAMMED AND SHOWED 73%. BATTERY LIFE WAS NOTED INITIALLY AS HAVING ONLY 2.5 YRS LEFT UNTIL REPLACEMENT. AFTER PROGRAMMING IT SHOWED APPROXIMATELY 6.5 YRS TIME TO EXPLANT. PT ADVISED TO F/U IN ONE WEEK. THERE IS CONCERN THAT THIS DEVICE IS EXPERIENCING RAPID BATTERY DEPLETION WHICH IT SHOULD NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BSI ICD ICD NIK BOSTON SCIENTIFIC, INC. BS CRTD N119
    2 GUIDANT LEAD LEAD LWS GUIDANT 4542
    3 GUIDANT LEAD LEAD LWS GUIDANT 4086
    4 GUIDANT LEAD LEAD LWS GUIDANT 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other