BEUDAMED
    FDA Adverse Event Summary report: N

    VENTAK MINI AICD

    MDR report key: 34296 · Received July 19, 1996

    Report

    Report Number
    MW4001412
    Date Received
    July 19, 1996
    Date of Event
    April 23, 1996
    Report Date
    July 2, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 4/23/96, RPTR HAD THE PACEMAKER IMPLANTED. ON TWO SEPARATE OCCASIONS, IT GAVE HIM A RIB SHOCK WHICH SEEMED TO COINCIDE WITH TAKING HIS BLOOD PRESSURE. ON 5/9/96, THE PACEMAKER WAS REMOVED AND ANOTHER ONE PUT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK MINI AICD AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1740

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR