BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2161576 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-06873
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IMPLANTED. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE ALERT WAS ISSUED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED WITH ANOTHER MANUFACTURER'S DEFIBRILLATION LEAD, DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. NOISE WAS ALSO OBSERVED ON THE RATE/SENSE CHANNEL ELECTROGRAMS. NO INAPPROPRIATE THERAPY WAS DELIVERED DUE TO THE NOISE. IT WAS REPORTED THAT A FRACTURE WAS SUSPECTED ON THE LEAD. THE PHYSICIAN ELECTED TO PROGRAM TACHY THERAPY OFF TO PREVENT INAPPROPRIATE THERAPY AS NO INTERVENTION IS PLANNED. 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 84 YR 4076| E110| 7288| 6949