BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1951979 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23163
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY THIS DEVICE WAS RETURNED AND THE BATTERY STATUS WAS FOUND TO BE AT END OF LIFE (EOL). VISUAL INSPECTION OF THE DEVICE NOTED AN ARC MARK ON THE BACK OF DEVICE. THE DEVICE MEMORY SHOWED THAT THE LAST SHOCK DELIVERED WAS A FULL ENERGY SHOCK AND MINUTES LATER EOL WAS DECLARED FROM A CHARGE TIMEOUT DURING THE NEXT ATTEMPT TO CHARGE. AN X-RAY SHOWED THAT THE PLASMA FUSE WAS OPEN, WHICH WILL CAUSE CHARGE TIMEOUTS TO OCCUR. LABORATORY ANALYSIS CONFIRMED THAT THE ARC MARK ON THE DEVICE AS WELL AS AN OPEN PLASMA FUSE ARE INDICATIONS THAT THE DEVICE SHOCKED INTO A SHORTED LEAD.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY A REVISION TOOK PLACE. DURING THE REVISION ALL ELECTRICAL MEASUREMENTS APPEARED NORMAL. THE PATIENT IS STABLE AND IS AWAITING A HEART TRANSPLANT. THE LEADS WERE NOT REMOVED DUE TO A THROMBUS IN THE ATRIUM. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS REQUESTED BY THE CUSTOMER BUT SOME FILES WERE MISSING FROM THE DATA DISK. WITH THE AVAILABLE INFORMATION ENGINEERS COULD ONLY SPECULATE THE CAUSE OF THE PREMATURE EOL WAS DUE TO A SHORTER LEAD. IT WAS CONFIRMED THAT THE LEAD IS A COMPETITOR LEAD. AT THIS TIME NO ADDITIONAL INFORMATION IS AVAILABLE, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    A DATA DISK ANALYZED BY TECHNICAL SERVICES REVEALED SEVERAL SYSTEM FAULTS. IT WAS CONFIRMED THAT THE DATA SUGGESTS THAT THE DEVICE IS NO LONGER CAPABLE OF CHARGING ITS INTERNAL HIGH VOLTAGE CAPACITORS. IT WAS ALSO DISCUSSED THAT IT IS POSSIBLE THAT THE DAMAGE WAS DUE TO A COMPROMISED LEAD SYSTEM, EXTERNAL DEFIBRILLATION ENERGY, OR ELECTROCAUTERY. IT WAS ADVISED TO RETURN THE DEVICE SO FULL ANALYSIS COULD DETERMINE THE ROOT CAUSE OF THE ISSUE. THE LEAD IMPLANTED IS A COMPETITOR LEAD.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS EVENT WILL BE UPDATED AND FILED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HEARD BEEPING TONES EMITTED FROM THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). DEVICE INTERROGATION SHOWED THAT THE DEVICE HAD DECLARED END OF LIFE (EOL). DUE TO THE PATIENT BEING WEAK A REPLACEMENT PROCEDURE HAS NOT BEEN PERFORMED. THE PATIENT REMAINS HOSPITALIZED. PREMATURE BATTERY DEPLETION WAS ALLEGED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1