BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2170391 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10335
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    December 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

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE PATIENT WAS SEEN IN CLINIC FOR FOLLOW UP. THE FOLLOW UP TESTING SHOWED NO ABNORMALITIES ON THE LEAD OR OTHER COMPONENTS OF THE SYSTEM. THE LEAD FUNCTION WAS NORMAL WITH NORMAL IMPEDANCES. THE PLAN GOING FORWARD IT TO MONITOR THE PATIENT ACCORDING TO TYPICAL FOLLOW UP REGIMEN. NO CHANGES WILL BE MADE TO THE PATIENTS FOLLOW UP SCHEDULE. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED A LOW, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.

    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 77 YR 4135| E110| 0185