BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 3775689 · Received April 22, 2014

    Report

    Report Number
    MW5035769
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE BEEPED AND PATIENT CALLED DEVICE CLINIC, AND WAS SEEN ON (B)(6) 2014. RECEIVED AN "OUT OF SCHEDULE REMOTE TRANSMISSION." PATIENT CAME IN ON (B)(6) 2014 TO HAVE THE DEVICE REPLACED. SIMILAR DEVICES ARE ON RECALL, BUT NOT HIS SERIAL NUMBER. DATE OF USE: IMPLANTED ON (B)(6) 2009. REASON FOR USE: HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244614 BOSTON SCIENTIFIC DEFIBRILLATOR LWS BOSTON SCIENTIFIC E110

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention