BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1951942 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23031
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 19, 2010
    Report Date
    May 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. 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

    RV IMPEDANCE MEASUREMENTS CONTINUED TO MEASURE GREATER THAN 2,000 OHMS. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC. THE RV LEAD WAS NOTED TO HAVE A HIGH RV LEAD IMPEDANCE AS WELL AS A HIGH THRESHOLD AT THE TIME OF HIS IMPLANT. THE CLINIC CONTINUED TO MONITOR THIS PATIENT AT THIS TIME, WITH NO INTERVENTION PERFORMED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE ALERT DETECTED AN INCREASED RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENT. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH 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 55 YR T127| E110| 4470| 0175