BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1945027 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20857
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    January 19, 2010
    Report Date
    October 4, 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

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED INCREASED RIGHT ATRIAL IMPEDANCES FROM 600 TO 1500 OHMS. MEASUREMENTS WERE NEVER OUT OF RANGE AND WERE INCREASED FOR ONLY A SHORT TIME, THEN DECREASED. TECHNICAL SERVICES (TS) REVIEWED THE ARRHYTHMIA LOGBOOK AND PRESENTING ELECTROGRAMS AND NOTED THERE WAS NO NOISE. THEY SUGGESTED BRINGING THE PATIENT IN FOR LEAD TESTING TO INCLUDE ISOMETRICS. THEY OTHERWISE RECOMMENDED CONTINUED MONITORING FOR RIGHT NOW. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    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
    1 303 MO (B)(4)| (B)(4)| (B)(4)| (B)(4)