BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1873890 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17881
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 31, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE AND VENTRICULAR LEAD REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT A LATER DATE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT POST THIS IMPLANT PROCEDURE, VENTRICULAR PACING AT 120 PPM WAS NOTED BRIEFLY ON TELEMETRY. THE DEVICE WAS INTERROGATED AND TWO EPISODES OF WENCKEBACH WERE NOTED ON THE COUNTERS. THE PATIENT ALSO HAD A FEW RUNS OF PRE ATRIAL AND PRE VENTRICULAR CONTRACTION'S. THEN TWO WEEKS LATER, IT WAS NOTED THIS PATIENT HAS HAD 61 VENTRICULAR TACHYCARDIA (VT) EPISODES STORED FROM IMPLANT TO FOUR DAYS LATER, THEN NO MORE. TECHNICAL SERVICES DISCUSSED POSSIBLE LOSS OF CAPTURE. THE DEVICE WAS INTERROGATED AGAIN AND THE SALES REPRESENTATIVE (SR) OBSERVED THE SAME ISSUE. SHE NOTED THE VENTRICULAR THRESHOLDS WERE FAR BELOW THE OUTPUT PROGRAMMED ON THE DEVICE. THE OUTPUTS WERE INCREASED TO 5V. THE SR ALSO NOTED THERE WAS AN ATRIAL TACHY RESPONSE (ATR) AS SHE SAW 4 FAST BEATS AT THE BEGINNING OF THE STRIP, 3 WHICH WERE MARKED AND 1 IN REFRACTORY. NOTED IN THE MIDDLE OF THE STRIP THERE WAS AN ATR FALL BACK. TS EXPLAINED THE PATIENT'S EXIT COUNT WAS NOT MET PRIOR TO DURATION, SO AN ATR FALL BACK WAS INITIATED. THE SR CONFIRMED FROM FLUOROSCOPY THAT THE VENTRICULAR LEAD WAS IN A GOOD POSITON AND DID NOT APPEAR TO HAVE MOVED SINCE IMPLANT. THE PATIENT IS SCHEDULED FOR ANOTHER FOLLOW UP DEVICE CHECK IN THE NEXT MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S404

    Patients

    Seq Age Sex Outcome Treatment
    1