BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2040109 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00508
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 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

    LATITUDE MONITORING OF THE LEAD WAS DISCUSSED. INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN-SERVICE. INVESTIGATION IS COMPLETED AND THIS EVENT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED ONE OUT OF RANGE HIGH PACING IMPEDANCES ON THIS TRANSVENOUS LEAD. IT WAS REPORTED THAT THE LEAD HAD BEEN STABLE AROUND 536 OHMS BUT DID NOTE A 1619 OHM MEASUREMENT AS WELL. 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 81 YR 4469| E110| 0157| 1861