BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1950618 · Received January 6, 2011

    Report

    Report Number
    2124215-2011-00186
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS CLINIC NURSE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS DEVICE AND COMPETITOR RIGHT ATRIAL (RA) LEAD IS EXHIBITING A GREATER THAN 2000 OHMS RA PACING IMPEDANCE MEASUREMENT SINCE (B)(6) 2010. THE LAST OFFICE CHECK OCCURRED IN EARLY (B)(6) 2010. THERE HAS BEEN NO ELECTROGRAM NOISE IDENTIFIED AND THE P-WAVES HAVE REMAINED STABLE. NO ADDITIONAL INFORMATION WAS AVAILABLE FROM THE FIELD. THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS INSERVICE.

    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 71 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)