BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2173225 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11063
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 1, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM LAB ANALYSIS SHOWED THE DEVICE EXHIBITED MEMORY CORRUPTION. UPON MEMORY DUMP, THE DEVICE INFORMATION WAS STORED UNDER THE WRONG DEVICE. BECAUSE OF THE INCORRECT MODEL/SERIAL INFORMATION, A MEMORY DOWNLOAD COULD NOT BE PERFORMED. WITH TTM ALL TELEMETRY OPERATIONS ARE NORMAL AND THE HEX MEMORY DOWNLOAD IS COMPLETE, BUT MEMORY WAS VERIFIED TO BE CORRUPT. DEVICE WAS LOADED WITH A KNOWN GOOD MEMORY, FOR TESTING PURPOSES. A VISUAL EXAM SHOWED MARKS THAT WOULD INDICATE A DEVICE LIKE A ELECTRO CAUTERY DISCHARGE TO THE CASE MAY HAVE OCCURRED. MEMORY COULD HAVE BEEN CORRUPTED DUE TO COLD OR ELECTROCAUTERY. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. DEVICE FUNCTIONS ELECTRICALLY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS OF THE DEVICE FOUND A FAILURE DUE TO MEMORY CORRUPTION. FURTHER ANALYSIS IS BEING COMPLETED TO DETERMINE ROOT CAUSE. ONCE THE ANALYSIS HAS BEEN COMPLETED THIS REPORT WILL BE UPDATED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS RETURNED WITH NO ADDITIONAL INFORMATION. THERE WERE NO KNOWN ALLEGATIONS AGAINST THE DEVICE, AND NO REPORTS OF ADVERSE PATIENT EFFECTS. PRELIMINARY ANALYSIS DETERMINED THAT THE DEVICE FAILED DUE TO MEMORY CORRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR 1290| 4479| 4087| S606