BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOSE DR BIOTRONIK BATTERY

    MDR report key: 555810 · Received November 12, 2004

    Report

    Report Number
    555810
    Event Type
    Injury
    Date Received
    November 12, 2004
    Date of Event
    September 2, 2004
    Report Date
    November 8, 2004
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACEMAKER BATTERY CHANGE DUE TO MALFUNCTIONING PREVIOUS BATTERY. ON PACEMAKER FOLLOW UP PHYSICIAN WAS UNABLE TO INTERROGATE BATTERY. BATTERY CHANGED AND PT IS DOING MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOSE DR BIOTRONIK BATTERY PACEMAKER BATTERY DSZ BIOTRONIK, INC. 28101971 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization