BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2810099 · Received October 31, 2012

    Report

    Report Number
    2124215-2012-14824
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    January 12, 2011
    Report Date
    August 21, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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 EVALUATED. A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE HAD GONE INTO SAFETY MODE ON (B)(4)-2010 AFTER EXPERIENCING THREE FAULTS. TECHNICIANS PROGRAMMED THE DEVICE OUT OF SAFETY MODE TO PERFORM ADDITIONAL TESTING. THE DEVICE WAS HEATED TO 45 DEGREES CELSIUS AND WAS MONITORED FOR SEVERAL DAYS, BUT NO DEVICE FAULTS COULD BE RECREATED. THE DEVICE THEN UNDERWENT VIBRATION CYCLE TESTING AND AGAIN, NO FAILURES WERE NOTED. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE DEVICE CASE WAS OPENED AND A VISUAL INSPECTION OF THE INTERNAL COMPONENTS NOTED NO ANOMALIES. THE CRYSTAL OSCILLATOR COMPONENT WAS REMOVED FOR DETAILED TESTING. AN X-RAY OF THE COMPONENT REVEALED THE PRESENCE OF FOREIGN MATERIAL INSIDE THE CRYSTAL. THIS FOREIGN MATERIAL INTERFERED WITH THE FUNCTION OF THE OSCILLATING CIRCUIT, RESULTING IN THE FAULTS THAT CAUSED THE DEVICE TO GO INTO SAFETY MODE. BY DESIGN, SAFETY MODE IN THIS FAMILY OF DEVICES WILL CAUSE THE DEVICE TO REVERT TO MONITOR + THERAPY MODE, ENSURING LIMITED PACING AND SHOCK THERAPY REMAIN AVAILABLE. THIS IS WHY THE DEVICE WAS DISCOVERED TO BE IN MONITOR+THERAPY MODE AT THE PRE-IMPLANT INTERROGATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT PROCEDURE; UPON INITIAL DEVICE INTERROGATION, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A FAULT CODE STATING THAT THE DEVICE WAS IN SAFETY MODE. THE DEVICE WAS THEN PROGRAMMED TO MONITOR PLUS THERAPY; HOWEVER, AN ERROR MESSAGE WAS RECEIVED. THE DECISION WAS MADE NOT TO IMPLANT THIS DEVICE. THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1