BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1864161 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16037
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    June 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS ELECTIVELY EXPLANTED OVER NINE MONTHS LATER AND RETURNED FOR ANLAYSIS.

    Additional Manufacturer Narrative · 1

    UPON RETURN TO OUR QUALITY ASSURANCE LABORATORY THE DEVICE UNDERWENT DETAILED ANALYSIS. THERE WERE NO SIGNS OF ABNORMALITY OR MISHANDLING ON THE HEADER NOR ON THE CAN OF THE DEVICE. AN X-RAY VERIFIED THAT THERE WERE NO CROSS THREADS ON ANY OF THE SETSCREWS AND THAT THE LEAD WIRES INSIDE THE HEADER WERE INTACT. THE PIN GAGE TESTING ON DF+ AND DF- PORTS ALSO INDICATED THAT BOTH SHOCK LEAD PORTS WERE ALSO NORMAL. PER MEMORY LOG REPORT, NO FAULT CODES WERE RECORDED WHILE THE DEVICE WAS IMPLANTED. 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 WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. IN CONCLUSION, THE REPORTED FIELD ALLEGATIONS COULD NOT BE CONFIRMED THROUGH ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT > 2000 OHMS AND HIGH THRESHOLDS WAS DETECTED ON THIS DEFIBRILLATION LEAD. THERE WAS ALSO REPORT OF SMALL BASELINE NOISE. THE PATIENT WAS SCHEDULED FOR A LEAD REVISION. RESOLUTION WAS REQUESTED FROM THE FIELD REPRESENTATIVE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE LEAD WAS NOT FULLY INSERTED THROUGH THE CONNECTOR BLOCK. THE SET SCREW WAS LOOSENED, THE LEAD TESTED ON THE PACING SYSTEM ANALYZER, AND REINSERTED INTO HEADER. IMPEDANCE WAS THEN 426 OHMS. FURTHER, UPON VISUAL INSPECTION OF THE 4470 THE OUTER LAYER OF INSULATION WAS FOUND TO BE CRACKED 1.5 TO 2 INCHES FROM THE PROXIMAL END OF THE LEAD. TECHNICAL SERVICES ADVISED NO WAY TO REPAIR AND THAT A NEW LEAD SHOULD BE IMPLANTED. THE PHYSICIAN CHOSE TO SURGICALLY ABANDON THIS LEAD AND REPLACE IT WITH A NON-BOSTON SCIENTIFIC LEAD. 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 E110

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 5076| T125| 4470| 0175| 0185| E110