BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1951440 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22911
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 6, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WITH THE CHRONIC IMPLANTABLE DEFIBRILLATION LEAD, NOISE WAS OBSERVED ON THE RATE/SENSE CHANNEL. PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS AND LOSS OF CAPTURE WERE ALSO OBSERVED. THE LEAD WAS REINSERTED INTO THE DEVICE HOWEVER LOSS OF CAPTURE WAS STILL OBSERVED. MINERAL OIL WAS USED TO REINSERT THE LEAD A SECOND TIME. ALL MEASUREMENTS WERE THEN ACCEPTABLE AND NO FURTHER NOISE WAS OBSERVED. 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 72 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)