BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1870580 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-16967
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-1293-06 THRU Z1299-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF THE DEVICE MEMORY INDICATED THE DEVICE REACHED ELECTIVE REPLACEMENT TIME (ERT) DUE TO THE DEVICE BEING PROGRAMMED TO HIGHER OUTPUTS. BASED ON THRESHOLD MEASUREMENTS TAKEN IN THE FIELD AND PACING VALUES A LONGEVITY CALCULATION CONFIRMED THIS DEVICE WAS ON TRACK FOR NORMAL DEPLETION. NORMAL PACING AND SENSING FUNCTIONS WERE ALSO CONFIRMED WITH TESTING. LABORATORY TESTING CONFIRMED THIS DEVICE DID NOT EXHIBIT ANY ANOMALIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE REACHED ELECTIVE REPLACEMENT TIME (ERT) AND BEING REPLACED. IT WAS NOTED THAT ONE MONTH AGO, THE DEVICE BATTERY INDICATOR SHOWED ONE YEAR REMAINING, NOW IT'S AT ERT. THE PACING OUTPUTS WERE INCREASED DUE TO THE PATIENT'S INCONSISTENT THRESHOLD MEASUREMENTS, HOWEVER THE PHYSICIAN BELIEVES THE DEVICE STILL PREMATURELY DEPLETED DUE TO THE DISCREPANCY IN LONGEVITY BETWEEN LAST MONTH AND TODAY. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1296

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR S602| 1296| 1388T