BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1953962 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24060
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE EXHIBITED NO TELEMETRY. THE HEADER AND CASE OF THE DEVICE WERE REMOVED AND THE BATTERY MEASURED AT .312 VOLTS, WITH NO POWER SUPPLY FUNCTION. THE DEVICE WAS HOOKED UP TO AN EXTERNAL POWER SUPPLY, WHICH FAILED CONTINUITY TESTS. IT WAS CONFIRMED THAT DAMAGED WIRE INSULATION RESULTED IN A HIGH CURRENT CONDITION, CAUSING RAPID BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED WITH MULTIPLE PROGRAMMER RECORDER MONITORS (PRM). ADDITIONALLY, NO TONES WERE EXHIBITED WITH MAGNET PLACEMENT. TECHNICAL SERVICES (TS) DISCUSSED RECOMMENDATIONS FOR FURTHER EVALUATION. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER EXPLANTED AS A RESULT OF NOT BEING ABLE TO BE INTERROGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 0157| N118| H175| 4517| 4087