BEUDAMED
    FDA Adverse Event Other Summary report: N

    CPI

    MDR report key: 124876 · Received September 29, 1997

    Report

    Report Number
    MW4002011
    Event Type
    Other
    Date Received
    September 29, 1997
    Date of Event
    July 21, 1997
    Report Date
    September 29, 1997
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN DIAGNOSED FAILURE OF AICD LEAD AND DEFIBRILLATOR REPLACEMENT REQUIRING REMOVAL OF OLD SYSTEM/NEW LEAD REPLACEMENT. THE PT UNDERWENT GENERATOR REPLACEMENT (DEFIBRILLATOR) AT THE SAME TIME SINCE HE HAD ONE OF THE OLD LARGE GENERATORS IN HIS LEFT ABDOMINAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPI Implant AICD LEAD LWS CARDIAC PACEMAKERS, INC. 0065 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other