BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1853932 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-16534
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 17, 2010
    Report Date
    August 29, 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

    AVAILABLE INFORMATION SUGGESTS THAT THIS RV LEAD REMAINS IMPLANTED AND IN SERVICE, AND THAT THE PHYSICIAN IS MONITORING THE LEAD IMPEDANCE MEASUREMENTS AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT THIS IS A DEVICE SPECIFIC ISSUE, NOT A LEAD ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SINGLE LOW SHOCK IMPEDANCE MEASUREMENT OF LESS THAN 20 OHMS, TRIGGERING A LATITUDE RED ALERT. THE PATIENT WAS BROUGHT IN CLINIC, WHERE TESTING OF THIS RV LEAD FOUND NOTHING ABNORMAL. NO ADVERSE PATIENT EFFECTS HAVE OCCURRED AS A RESULT OF THESE OBSERVATIONS.

    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 63 YR E102| 0184