BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC PACEMAKERS, INC.

    MDR report key: 61401 · Received January 3, 1997

    Report

    Report Number
    61401
    Event Type
    Injury
    Date Received
    January 3, 1997
    Date of Event
    December 20, 1996
    Report Date
    January 3, 1997
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACEMAKER AT END OF LIFE AFTER 2 YRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKERS, INC. Implant PACEMAKER DXY CARDIAC PACEMAKERS, INC. 940-701642 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R