BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1874998 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17905
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 6, 2010
    Report Date
    November 22, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THIS ICD WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES AND NO EVIDENCE THAT THE HEADER HAD BECOME LOOSENED WHILE IMPLANTED. ALL SETSCREWS MOVED FREELY AND WITHOUT ISSUE. MICROSCOPIC ANALYSIS FOUND THAT ALL THE SEAL PLUGS WERE INTACT. MEASUREMENTS WERE THEN TAKEN ON EACH PORT TO ENSURE THEY ARE THE SPECIFIED SIZE AND THAT THE IS-1 PIN HAS PROPER CONTACT WHEN INSERTED. THE PORTS ON THIS DEVICE WERE FOUND TO BE WITHIN SPECIFICATION. THE DEVICE WAS THEN 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. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE FIELD OBSERVATIONS OF LOSS OF CAPTURE, HIGH PACING THRESHOLDS AND OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THIS DEVICE WAS FOUND TO BE OPERATING NORMALLY AND WITHIN ALL SPECIFICATIONS. IN ADDITION, LABORATORY ANALYSIS FOUND NO EVIDENCE THAT THIS DEVICE HAD EXPERIENCED THE MALFUNCTION DESCRIBED IN THE SUBPECTORAL IMPLANT ADVISORY.

    Additional Manufacturer Narrative · 1

    THE ICD WAS REPROGRAMMED AND A REPLACEMENT HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION AVAILABLE. ONCE THE DEVICE HAS BEEN EXPLANTED, RETURNED, AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE ICD WAS REPLACED AND RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ADMITTED TO THE HOSPITAL AFTER PRESENTING WITH LOSS OF RIGHT VENTRICULAR CAPTURE, INCREASE IN PACING THRESHOLDS, AND A PACING IMPEDANCE MEASUREMENT ABOVE 2000 OHMS. THIS ICD IS IMPLANTED SUBPECTORALLY AND IT IS PART OF THE SUBPECTORAL IMPLANT ADVISORY, INITIALLY COMMUNICATED ON DECEMBER 1, 2009. AN X-RAY WAS PERFORMED AND IT APPEARED THAT THE ASSOCIATED RIGHT VENTRICULAR DEFIBRILLATION LEAD MAY BE FRACTURED. THIS LEAD IS A COMPETITOR'S PRODUCT. HOWEVER, BECAUSE THE BEHAVIOR IS ALSO INDICATIVE OF THE ADVISORY, THE ICD WILL BE EXPLANTED AND RETURNED FOR LABORATORY 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 F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention