BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1890024 · Received November 3, 2010

    Report

    Report Number
    2124215-2010-21317
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    May 27, 2009
    Report Date
    August 6, 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

    THE BOSTON SCIENTIFIC TECHNICAL SERVICES DEPARTMENT RECOMMENDED CONSIDERING BRINGING THE PATIENT IN CLINIC TO EVALUATE THE COMPETITIVE RA LEAD. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME, AND CURRENT RECORDS SUGGEST THAT THESE PRODUCTS REMAIN IMPLANTED AND IN SERVICE. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND COMPETITIVE RIGHT ATRIAL (RA) LEAD DETECTED A PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS, TRIGGERING A LATITUDE ALERT. P-WAVES REMAINED STEADY, BUT SOME OVERSENSED NOISE WAS NOTED IN THE COMPETITIVE RA LEAD. THE PATIENT DOES NOT REQUIRE A SIGNIFICANT AMOUNT OF ATRIAL PACING, AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 80 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)