BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2913203 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17135
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    September 10, 2012
    Report Date
    February 27, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROGRAMMED CONFIGURATION WAS REPROGRAMMED TO RV COIL TO CAN AND ACCEPTABLE SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED. THE PHYSICIAN WILL CONTINUE TO MONITOR THE DEVICE AND LEAD AND CONSIDER DEFIBRILLATION THRESHOLD (DFT) TESTING IN THE FUTURE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT THIS PRODUCT WAS EXPLANTED AND REPLACED TWO MONTHS LATER. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE LOCAL FIELD REPRESENTATIVE THAT AFTER THE SHOCKING CONFIGURATION HAD BEEN REPROGRAMMED, DEFIBRILLATION THRESHOLD (DFT) TESTING WAS COMPLETED SUCCESSFULLY AND REVEALED STABLE MEASUREMENTS. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS THAT WERE ABLE TO BE REPRODUCED WITH POCKET MANIPULATION. IT WAS NOTED THAT THE SHOCK VECTOR HAD BEEN PROGRAMMED TRIAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBILITY OF A LEAD INSULATION ISSUE VERSUS A CONNECTION ISSUE AND DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19742 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R E102| 0184| 4136| T175