BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3040730 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03125
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 5, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OUT OF RANGE PACING IMPEDANCES WERE DETECTED. THERE WERE NO ADVERSE PATIENT EFFECTS. NO IMMEDIATE INFORMATION WAS AVAILABLE. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143219 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 4469| E110| 0147