BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPI BY GUIDANT CORP

    MDR report key: 196905 · Received October 21, 1998

    Report

    Report Number
    MW1014953
    Event Type
    Injury
    Date Received
    October 21, 1998
    Date of Event
    October 15, 1998
    Report Date
    October 21, 1998
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PACEMAKER IMPLANTED ON 3/26/92. EQUIPMENT LIFE-EXPECTANCY WAS MET, PACEMAKER GENERATOR HAD TO BE REPLACED. PACEMAKER GENERATOR WAS 6.5 YEARS OLD, PROBABLY DO NOT NEED TO REPORT MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPI BY GUIDANT CORP Implant PACEMAKER GENERATOR DXY CARDIAC PACEMAKERS, INC. 0940 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R SURGERY PERFORMED ON 10-15-98.