BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2172930 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10812
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE RIGHT VENTRICULAR PACING IMPEDANCE MEASUREMENTS. REVIEW OF LEAD MEASUREMENTS REVEALED VARYING PACING IMPEDANCE MEASUREMENTS FROM THE 1,200 - 1,300 OHMS RANGE TO THE 500 - 600 OHMS RANGE. TECHNICAL SERVICES DISCUSSED BRINGING THE PATIENT IN FOR FURTHER EVALUATION. 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 E102

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4136| E102| 0148| 1860