BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2911319 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16054
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 28, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS TRIGGERED DUE TO OUT OF RANGE PACING IMPEDANCES. A REVIEW OF THE WEBSITE BY TECHNICAL SERVICES NOTED THAT THE PACING IMPEDANCES HAVE BEEN INTERMITTENTLY HIGH, BUT THE TREND WAS NORMALLY WITHIN NORMAL RANGE. ALL ELECTROCARDIOGRAMS APPEARED TO BE FREE OF NOISE. AT THIS TIME THE DEVICE REMAINS AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18029 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1