BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3231964 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11212
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS WAS UNABLE TO CONFIRM FIELD OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS BEING UPGRADED FROM A SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LEFT VENTRICULAR (LV) AND RIGHT ATRIAL (RA) LEADS WERE SUCCESSFULLY IMPLANTED. WHEN THE CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS ATTACHED TO THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ((B)(4)) THERE WERE INTERMITTENT PAUSES NOTED ON THE MONITOR; STRIPS SHOWED THAT ATRIAL PACED AND ATRIAL SENSED BEATS PERIODICALLY RESULTED IN OVERSENSING AND PACING INHIBITION ON THE RV ELECTROGRAM (EGM). THE PATIENT WAS PACEMAKER DEPENDENT AND PAUSES GREATER THAN TWO SECONDS WERE OCCASIONALLY OBSERVED. CONNECTIONS WERE CHECKED MULTIPLE TIMES, PROGRAMMING PARAMETERS WERE MODIFIED AND THE ISSUE WAS STILL NOTED. A SECOND CRT-D ((B)(4)) WAS OPENED, USED, AND YIELDED THE SAME RESULTS. IN VVI MODE THERE WAS NORMAL FUNCTION, HOWEVER, THE PHYSICIAN DID NOT WANT THE DEVICE PROGRAMMED VVI, NOR DID HE WANT TO REVISE THE LEADS. THEREFORE, A COMPETITOR'S DEVICE WAS THEN CONNECTED WITH SIMILAR OBSERVATIONS NOTED, HOWEVER, DUE TO AN AVAILABLE PACING ALGORITHM RV PACING REMAINED AVAILABLE AND WITH A DECREASED RV SENSITIVITY THE OVERSENSING APPEARED RESOLVED. THE COMPETITOR'S GENERATOR REMAINED IN SERVICE WITH THE CHRONIC RV LEAD AND NEWLY IMPLANTED RA AND LV LEADS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332360 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 0184| 4542| E102| N161