BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3905282 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10302
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 1, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF DEVICE MEMORY CONFIRMED A SINGLE BIT MEMORY CORRUPTION IN THE MEMORY USED FOR THE COUNTER DATA. THE DEVICE TOTALS DATA WILL ALWAYS BE OFF, BUT THE SINCE LAST RESET OR LAST FOLLOW UP DATA WILL BE CORRECT ONCE THE COUNTERS ARE RESET AND THE PATIENT IS DISMISSED FROM THE SCHEDULED REMOTE FOLLOW UP IN THE REMOTE MONITORING SYSTEM. ANALYSIS CONCLUDED THERE WAS NO REASON TO BELIEVE THERE WAS ANY IMPACT TO DEVICE FUNCTION. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE INTERROGATION DATA FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED SEVERAL THOUSAND TREATED VENTRICULAR TACHYCARDIA (VT) THERAPY EPISODES, HOWEVER, REVIEW OF STORED DEVICE MEMORY SHOWED ONLY ONE EPISODE OF ANTI-TACHYCARDIA PACING (ATP) DELIVERY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBILITY OF MEMORY CORRUPTION IN THE EPISODE COUNTER PORTION OF DATA WHICH WAS NON-CRITICAL DATA, SO THE DEVICE WOULD OPERATE APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A COPY OF DEVICE MEMORY WAS SUBMITTED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382106 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR T125| 0185| E163| 4086| 0184