BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1861101 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15435
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESOLUTION WAS REQUESTED FROM THE FIELD, HOWEVER, NOTHING FURTHER HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE LEAD WAS SURGICALLY ABANDONED AND A NEW BOSTON SCIENTIFIC LEAD WAS IMPLANTED SUCCESSFULLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED >2000 OHMS ON A NON-BOSTON SCIENTIFIC DEFIBRILLATION LEAD. NOISE WAS ALSO PRESENT ON THIS LEAD. THIS PATIENT IS NOT DEVICE-DEPENDANT. THE HEALTH CARE PROVIDER REPORTED NOT BEING ABLE TO LOCATE THE MEASUREMENT IN LATITUDE. 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 61 YR 6949| E110| 4470| T167