BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2052631 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03439
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 1, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY DETERMINED THAT THE DEVICE HAD NORMAL TELEMETRY OPERATIONS, AS WELL AS NORMAL PACING AND SENSING FUNCTIONS. A REVIEW OF THE DEVICE'S MEMORY REVEALED THAT A RATE FAULT RESET WAS STORED IN THE RESET COUNTER. LABORATORY TESTING HAS SHOWN THAT THE AUTO LEAD DETECT FEATURE CAN CAUSE A RATE FAULT RESET TO OCCUR, DUE TO THE MAX TRACKING RATE PROTECTION NOT BEING INITIALIZED. THIS TYPE OF RESET OCCURS PRIOR TO LEAD ATTACHMENT. ONCE A LEAD IS DETECTED, THE AUTO LEAD DETECT FEATURE WILL BE DISABLED, ALLOWING THE MAX TRACKING RATE PROTECTION TO BE INITIALIZED, PREVENTING THE RATE FAULT RESETS FROM OCCURRING. THIS RESET IS NORMAL DIAGNOSTIC BEHAVIOR AND DOES NOT HAVE ANY IMPACT ON THE THERAPY PROVIDED TO THE PATIENT. THE DEVICE PERFORMED NORMALLY THROUGHOUT ANALYSIS AND WAS FOUND TO BE FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS DEVICE IS UNDERGOING DETAILED ANALYSIS. WHEN ANALYSIS IS COMPLETE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED BECAUSE THE PATIENT NEEDED THEIR THERAPY UPGRADED DUE TO THE PATIENT'S CONDITION. THERE WAS NO ALLEGATION FROM THE FIELD REGARDING THE FUNCTION OF THE DEVICE. THIS EVENT WAS CREATED DUE TO THE INITIAL TESTING PERFORMED BY OUR POST MARKET QUALITY ASSURANCE LABORATORY. INITIAL TESTING NOTED A POSSIBLE PERFORMANCE ISSUE CONCERNING A RATE FAULT RESET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1194

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4469| S603| 1194| 4470