BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3211183 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07923
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    March 7, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. 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

    BOSTON SCIENTIFIC RECEIVED NEW INFORMATION THAT THIS ICD AND LEAD SYSTEM WAS EXPLANTED AND REPLACED. A LASER LEAD EXTRACTION PROCEDURE WAS PERFORMED TO REMOVE THE COMPETITIVE RA LEAD. A NEW DEVICE AND LEAD SYSTEM WAS IMPLANTED WITHOUT COMPLICATIONS. THE DEVICE WAS NOT RETURNED. 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ASSOCIATED NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. A LEAD FRACTURE WAS SUSPECTED BUT NOT CONFIRMED. THE CLINICIAN WANTED TO PROGRAM THE RA LEAD TO THE UNIPOLAR CONFIGURATION. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THAT UNIPOLAR CANNOT BE USED WITH ICDS, AND THAT THE RA LEAD COULD BE PROGRAMMED OFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310914 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 215 MO E110| 7122| 5076