BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 DR

    MDR report key: 711246 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-13091
    Event Type
    Injury
    Date Received
    May 9, 2006
    Date of Event
    January 9, 2006
    Report Date
    January 9, 2006
    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) AND THIS TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RATE/SENSE CHANNEL. THIS NOISE WAS OVERSENSED, RESULTING IN PACING INHIBITION. THE NOISE COULD BE OBSERVED, BUT WAS NOT SENSED, WITH THE PATIENT BEARING DOWN. LEAD MEASUREMENTS WERE STABLE AND WITHIN NORMAL RANGE. IT WAS REPORTED THAT THE PATIENT WAS CHOPPING WOOD DURING THE EPISODES OF NOISE. A GUIDANT TECHNICAL SERVICES CONSULTANT DISCUSSED THE POSSIBILITY OF A LOOSE SETSCREW RATHER THAN DIAPHRAGMATIC OVERSENSING. THERE WERE NO PATIENT SYMPTOMS REPORTED WITH THIS CLINICAL OBSERVATION. ADDITIONAL INFORMATION INDICATED THAT THE EPISODES WERE ACTUALLY OCCURRING AT NIGHT, WHILE THE PATIENT SLEPT. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED WITH NEW GUIDANT PRODUCTS.

    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 75 YR Required Intervention