BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2161553 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07361
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 15, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THIS DEVICE NOTED SMALL DENTS ON THE PG CASE, INDICATING THE DEVICE MAY HAVE BEEN ABUSED. DIAGNOSTIC TESTING OF DEVICE FUNCTIONS AND MEMORY WAS THEN COMPLETED. THE RESULTS OF THE TESTS INDICATED THE DEVICE HAD MEMORY CORRUPTION, AND THE ACCELEROMETER WAS NOT FUNCTIONING APPROPRIATELY. HIGH RESOLUTION X-RAY OF THE DEVICE FOUND A BROKEN INTERNAL COMPONENT WITHIN THE ACCELEROMETER. IT WAS CONCLUDED THIS CONDUCTIVE COMPONENT CONTACTED ANOTHER INTERNAL COMPONENT, CAUSING THE REPORTED OBSERVATIONS. THIS DEVICE ELECTRICALLY FUNCTIONED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS RETURNED WITH NO ALLEGATIONS. INITIAL LABORATORY ANALYSIS REVEALED MEMORY CORRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other