BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 7138504 · Received December 14, 2017

    Report

    Report Number
    MW5074155
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    December 11, 2017
    Report Date
    December 11, 2017
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT REQUIRED PREMATURE GENERATOR CHANGE OF ACCOLADE PACEMAKER. PACEMAKER IMPLANTED (B)(6) 2017. OFFICE NOTIFIED THROUGH REMOTE MONITORING THAT DEVICE RAPIDLY DEPLETING BATTERY LIFE. PT REQUIRED GENERATOR CHANGE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899372 BOSTON SCIENTIFIC PACEMAKER LWP BOSTON SCIENTIFIC L331

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention