BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR

    MDR report key: 711324 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-13001
    Event Type
    Malfunction
    Date Received
    May 9, 2006
    Date of Event
    November 10, 2005
    Report Date
    February 8, 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) EXHIBITED A SHOCK IMPEDANCE MEASUREMENT OF >125 OHMS. DAILY MEASUREMENTS SHOWED VARIED IMPEDANCE READINGS, WITH SOME THAT WERE OUT OF RANGE (>125). AN X-RAY SHOWED THAT THE DISTAL HIGH VOLTAGE PIN MAY NOT BE IN THE HEADER AS FAR AS THE PROXIMAL PIN. GUIDANT TECHNICAL SERVICES DISCUSSED CREATING NOISE ON THE EGRAMS, PERFORMING A SHOCK TO RE-CHECK THE IMPEDANCE MEASUREMENT, OR INVASIVELY CHECKING THE SETSCREWS. AS THE >125 OHMS MEASUREMENTS WERE INTERMITTENT AND ONLY IN THE DAILY MEASUREMENTS, THE PATIENT HAD RECEIVED A SHOCK RECENTLY, AND MULTIPLE MANUAL SHOCKING LEAD IMPEDANCE TESTS (SLIT) RESULTED IN NORMAL MEASUREMENTS. THE PHYSICIAN WILL MONITOR THE PATIENT. NEW INFORMATION REPORTS MORE >125 SHOCK IMPEDANCE MEASUREMENTS.

    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 74 YR Other