BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACE SETTER

    MDR report key: 49494 · Received November 7, 1996

    Report

    Report Number
    49494
    Event Type
    Injury
    Date Received
    November 7, 1996
    Date of Event
    September 25, 1996
    Report Date
    November 6, 1996
    Manufacturer
    METRONIC, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEAD IMPEDANCE, VENTRICULAR MORE THAN 2,700 OHMS. ON X-RAY LEAD WIRES WERE TWISTED IN POCKET, POSSIBLE LEAD FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACE SETTER Implant CARDIAC PACEMAKER DXY METRONIC, INC. 7074 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R