BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC PACEMAKERS, INC.

    MDR report key: 18845 · Received December 5, 1994

    Report

    Report Number
    18845
    Event Type
    Malfunction
    Date Received
    December 5, 1994
    Date of Event
    November 30, 1994
    Report Date
    December 5, 1994
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RETURNED TO OPERATING ROOM WITHIN 2 DAYS OF INSERTION OF PERMANENT PACEMAKER. QUESTIONABLE PROBLEM WITH PACEMAKER BATTERY WHICH WAS CHANGED. ORIGINAL BATTERY RETURNED TO MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKERS, INC. Implant PACEMAKER DXY CARDIAC PACEMAKERS, INC. 940

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other NEW IMPLANT ON 11/30/94.