BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3053655 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05067
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    September 8, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Additional Manufacturer Narrative · 1

    - -

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. HIGH POWERED VISUAL INSPECTION NOTED THAT THE SEAL RING MARKS ON THE RV LEAD BARREL INDICATE INCOMPLETE INSERTION. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A FOLLOW UP VISIT WAS PERFORMED. VENTRICULAR CHANNEL NOISE WAS OBSERVED. STIMULATION IMPEDANCE REMAINED HIGH OUT OF RANGE. THRESHOLDS WERE ALSO INCREASED. WHEN THE POCKET WAS MANEUVERED, NOISE COULD BE REPRODUCED. WHEN THE NOISE DISAPPEARED, NORMAL IMPEDANCE MEASUREMENTS WERE OBTAINED. A CONNECTION ISSUE IS SUSPECTED. A LEAD REVISION IS INTENDED, BUT NO SCHEDULED AS OF THIS DATE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. OTHER MEASUREMENTS WERE NORMAL. ISOMETRICS DID NOT REPRODUCE NOISE. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS PROVIDED A DATA DOWNLOAD FOR THEIR REVIEW. FURTHER ISOMETRICS AND A HIGH RESOLUTION X-RAY WERE RECOMMENDED TO VERIFY THE CONNECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THIS DEVICE WAS EXPLANTED FOR AN UNRELATED REASON. THE EXPLANTED DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. FURTHER SIMILAR ALERTS HAVE BEEN RECEIVED. REPORTEDLY, THE PHYSICIAN HAS BEEN AWARE OF THESE INCREASED MEASUREMENTS SINCE IMPLANT. A REVISION PROCEDURE WAS SCHEDULED BUT WAS CANCELLED. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156038 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 F102