BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 2163133 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07349
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    November 24, 2003
    Report Date
    April 21, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL SERVICES CONSULTANT EXPLAINED HOW TO RESET THE FAULT CODE AND PROGRAMMING OPTIONS TO REDUCE/PREVENT ITS RECURRENCE. UPON RECEIPT, THE CLINICAL OBSERVATIONS WERE CONFIRMED IN THE LABORATORY ENVIRONMENT BY GUIDANT'S RELIABILITY ASSURANCE LAB. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT THE DEVICE UNDERWENT A RESET, WHICH RESULTED IN THE OBSERVED ERROR MESSAGES. FOLLOWING THE RESET, THE DEVICE REVERTED TO A SAFETY FALLBACK MODE WITH LIMITED PROGRAMMABILITY, IN WHICH SINGLE ZONE PACING AND DEFIBRILLATION THERAPY WERE AVAILABLE. ANALYSIS RESULTS ARE CONSISTENT WITH DEVICES THAT HAVE BEEN EXPOSED TO RADIATION AND/OR A HIGH MAGNETIC FORCE, SUCH AS MAGNETIC RESONANCE IMAGING (MRI).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, UPON INTERROGATION, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A FAULT CODE. THIS FAULT CODE INDICATES THAT A PACING PULSE WAS ATTEMPTED TOO SOON AFTER A PREVIOUSLY DELIVERED PACING PULSE; PATIENTS WITH ATRIAL ARRHYTHMIA'S ARE ESPECIALLY SUSCEPTIBLE TO THIS OCCURRENCE. THE ICD IS OPERATING PER DESIGN AND THIS FAULT CODE DOES NOT REPRESENT A DEVICE MALFUNCTION. SUBSEQUENTLY, ADDITIONAL INFORMATION INDICATED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PRODUCING MUSCLE STIMULATION AND FOUND TO BE IN SAFETY MODE. NEW INFORMATION RECEIVED INDICATES THAT THE PATIENT HAS RETAINED LEGAL COUNSEL AND FILED A LAWSUIT. THERE WERE NO SPECIFIC ALLEGATIONS AGAINST THE FUNCTIONALITY OF THE DEVICE WITHIN THE CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CLONMEL IRELAND 1861

    Patients

    Seq Age Sex Outcome Treatment
    1 10448 DA 5568| MISMATCH| 1861| 0155