BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT

    MDR report key: 815895 · Received February 8, 2007

    Report

    Report Number
    2124215-2007-20096
    Event Type
    Malfunction
    Date Received
    February 8, 2007
    Date of Event
    November 30, 2006
    Report Date
    November 30, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z1107-9/05
    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 BOSTON SCIENTIFIC, CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS EXPLANTED DUE TO A CHARGE TIME 25.1 SECONDS. IT WAS SUSPECTED THAT THIS DEVICE DID NOT MEET ITS EXPECTED LONGEVITY DUE TO AN INCREASED CHARGE TIME. THE CHARGE TIME WAS 14.8 SECONDS ON AUGUST 25, 2006. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A NEW ICD WAS IMPLANTED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE ATRIAL GENERATOR LWS CARDIAC PACEMAKERS, INC A135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other