BEUDAMED
    FDA Adverse Event Summary report: N

    BOSTON SCIENTIFIC PACEMAKER

    MDR report key: 10683989 · Received October 14, 2020

    Report

    Report Number
    MW5097236
    Date Received
    October 14, 2020
    Manufacturer
    BOSTON SCIENTIFIC CRM CORP
    Product Code
    LWP
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT INQUIRED AS TO WHY HIS BATTERY WAS GOING DOWN SO QUICKLY; (B)(6) 2019 12.5 YEARS, (B)(6) 2019 13 YEARS; (B)(6) 2019 11 YEARS; (B)(6) 2019 10 YEARS; (B)(6) 2020 7.5 YEARS; (B)(6) 2020 6.5 YEARS. SENT DATA "DUMP" TO BOSTON SCIENTIFIC, RESULTS ARE EARLY BATTERY DEPLETION. REPLACE PACEMAKER WITHIN 90 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145790 BOSTON SCIENTIFIC PACEMAKER IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CRM CORP L121

    Patients

    Seq Age Sex Outcome Treatment
    1