BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3212632 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09921
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 27, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THIS DEVICE TO POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    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. AN IN SPECIFICATION IS-1 LEAD WAS USED TO DETERMINE THE POSITIONING OF THE IMPLANTED LEAD BY THE MARKS LEFT IN THE LEAD BARREL OF THE RIGHT VENTRICULAR LEAD CHANNEL BY THE SEALING RINGS OF THE IMPLANTED LEAD. IT IS CONFIRMED THAT THE RV LEAD HAD NOT BEEN FULLY INSERTED INTO THE LEAD BARREL DURING THE TIME OF IMPLANT. IT WAS SUSPECTED THE REPORTED ALLEGATION WAS DUE TO AN INCOMPLETE INSERTION OF THE RIGHT VENTRICULAR LEAD INTO THE LEAD BARREL AS EVIDENCED BY THE MARKS IN THE RIGHT VENTRICULAR LEAD BARREL. ANALYSIS DETERMINED THE DEVICE MET SPECIFICATION.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE AND CHRONIC RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS AND INCREASED THRESHOLDS. DURING A DEVICE CHANGE IN APPROXIMATELY EIGHT MONTHS EARLIER, NORMAL IMPEDANCE MEASUREMENTS WERE OBTAINED. AN INTERNAL TECHNICAL SERVICE (TS) CONSULTANT WAS CONTACTED REGARDING POSSIBLE REASONS FOR THIS ISSUE. TS REVIEWED THE INFORMATION AND DETERMINED COULD BE DUE TO UNDER INSERTION OF THE LEAD OR A LEAD FRACTURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED. THE POCKET WAS OPENED AND LEAD MEASUREMENTS OBTAINED WERE WITHIN NORMAL RANGE. THE LEAD WAS RE-SECURED IN THE DEVICE HEADER AND SIMILAR MEASUREMENTS WERE OBTAINED. WHILE CLOSING THE POCKET IMPEDANCE MEASUREMENTS BEGAN TO INCREASE. WHEN MEASURED WITH THE PSA, MEASUREMENTS WERE WITHIN RANGE. THERE WERE CONCERNS OF A POSSIBLE DEVICE HEADER ISSUE. A DECISION WAS MADE TO REPLACE THIS DEVICE. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. THE LEAD WAS RECONNECTED TO THE REPLACEMENT DEVICE AND ACCEPTABLE MEASUREMENTS WERE OBTAINED. REPORTEDLY DURING THE IMPLANT OF THIS SYSTEM; RESISTANCE HAD BEEN EXPERIENCED INSERTING THE RIGHT VENTRICULAR LEAD INTO THE DEVICE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312789 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R