BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERMEDICS, INC.

    MDR report key: 21273 · Received January 11, 1995

    Report

    Report Number
    21273
    Event Type
    Injury
    Date Received
    January 11, 1995
    Date of Event
    December 4, 1994
    Report Date
    December 6, 1994
    Manufacturer
    INTERMEDICS, INC.
    Product Code
    DSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACEMAKER BATTERY FAILURE WITHOUT WARNING, DESPITE PATIENT RECEIVING MONTHLY PACEMAKER CHECKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMEDICS, INC. Implant PACEMAKER - QUANTUM UNIPOLAR DSZ INTERMEDICS, INC. 253-19 (FROM 1988)

    Patients

    Seq Age Sex Outcome Treatment
    1 106 YR Required Intervention