BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY 2 DR

    MDR report key: 659568 · Received November 14, 2005

    Report

    Report Number
    2124215-2005-10928
    Event Type
    Death
    Date Received
    November 14, 2005
    Date of Event
    July 28, 2005
    Report Date
    July 28, 2005
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPIRED ONE DAY POST IMPLANT. THE PHYSICIAN IS CONCERNED THAT THE DEVICE DID NOT FUNCTION APPROPRIATELY. THE DEVICE WAS BURIED WITH THE PATIENT, BUT EPISODES WILL BE SENT IN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death