BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1253776 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40648
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 17, 2008
    Report Date
    August 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE RIGHT ATRIAL (RA) LEAD EXHIBITED INCREASED IMPEDANCE MEASUREMENTS FROM 800 OHMS TO GREATER THAN 3,000 OHMS DUE TO A POSSIBLE LEAD FRACTURE AND WAS SUBSEQUENTLY EXPLANTED. DURING THIS REVISION PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS NOT EASILY PLACED IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PORT, WHICH RESULTED IN FORCING THE LEAD IN THE HEADER. THE PHYSICIAN QUESTIONED THE RESISTANCE IN THE SPRING LEAFLETS ON THE PROXIMAL SPRING CONTACT AND DEVICE RELIABILITY. AN UNSUCCESSFUL ATTEMPT TO INDUCE WITH FIBH WAS NOTED. SHOCK ON T (SOT) RESULTED IN 4 ATTEMPTS, ALL UNSUCCESSFUL. EVENTUALLY, THE IMPLANTERS WERE FINALLY ABLE TO INDUCE SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS LATER EXPLANTED FOR AN UNSPECIFIED REASON AND RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other THE DEVICE 4086/204522 WAS IMPLANTED 23-JUN-2004| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2004| THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2004| THE DEVICE 6481 026526 WAS USED DURING THE EVENT.| THE DEVICE 0184/102865 WAS IMPLANTED 23-JUN-2004| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2004| THE DEVICE T125/108186 WAS IMPLANTED 23-JUN-2004