BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT

    MDR report key: 605382 · Received November 9, 2004

    Report

    Report Number
    2124215-2004-08611
    Event Type
    Malfunction
    Date Received
    November 9, 2004
    Date of Event
    August 2, 2004
    Report Date
    August 2, 2004
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH ATRIAL THERAPY CAPABILITIES EXHIBITED ATRIAL UNDERSENSING IN THIS PATIENT WITH ATRIAL FIBRILLATION. SINCE IMPLANT NO P WAVE MEASURMENTS HAVE BEEN REPORTED, THEREFORE, ALL DAILY MEASURMENTS ARE EITHER PACED OR NOT RECORDED. IMPEDANCE AND THRESHOLD MEASUREMENTS ARE NORMAL AND STABLE. IT IS ALSO REPORTED THAT ABOUT A WEEK PRIOR, THE PATIENT RECIEVED ANTI TACHICARDIA PACING (ATP) AND A SHOCK. ON STORED ELECTROGRAMS NO P-WAVES ARE DISCERNIBLE. THE ATRIAL PACING THRESHOLD NOW IS .8V, DOWN FROM 2 V AT IMPLANT. GUIDANT RECEIVED SUBSEQUENT INFORMATION THAT DURING THE EVACUATION OF A HEMATOMA AT THE DEVICE IMPLANT SITE (THE PATIENT WAS ON BLOOD THINNERS) THE SURGEON CUT THE IMPLANTABLE TRANSVENOUS DEFIBRILLATION LEAD.

    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 78 YR Other