BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANTABLE DEFIBRILLATOR/PACEMAKER/LEAD

    MDR report key: 32138 · Received January 31, 1996

    Report

    Report Number
    32138
    Date Received
    January 31, 1996
    Date of Event
    February 1, 1995
    Report Date
    November 8, 1995
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 71-YR-OLD MALE HAD UNDERGONE AICD PLACEMENT ON 2/95 NOTICED THAT HE WAS OVERSENSING, RECEIVED TWO SHOCKS THAT WERE NOT INDICATED. CARDIOLOGY NOTED EPISODES OF PAUSES 1.9 TO 2.3 SECONDS. ON 9/28/95 PT UNDERWENT REPLACEMENT OF AICD PACEMAKER, REMOVAL OF OLD GENERATOR AND PLACEMENT OF ANOTHER MODEL LEAD WAS REPOSITONED. THE PT SUBSEQUENTLY UNDERWENT REPLACEMENT OF SENSING V-LEAD ON 10/3/95 DUE TO PERSISTENT PAUSES ON TELEMETRY. THE PT TOLERATED THE PROCEDURE WELL AND WAS SUBSEQUENTLY DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE DEFIBRILLATOR/PACEMAKER/LEAD PACEMAKER/LEAD LWS CARDIAC PACEMAKERS, INC. 1705

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR