BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2042413 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02194
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THE NON-BSC TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID OVERSENSE T-WAVE ACTIVITY, LEADING TO UNNECESSARY THERAPY AND PATIENT HOSPITALIZATION. IMPEDANCE MEASUREMENTS APPEARED WITHIN NORMAL LIMITS, THRESHOLDS HAD NOT BEEN TESTED AT THE TIME OF THIS INITIALLY EVENT INFORMATION. THERE WAS NO EVIDENCE OF LEAD ISSUE SUCH AS NOISE. R WAVES WHICH HAD BEEN 10 MILLIVOLTS AT IMPLANT WERE NOW IN THE 2 MILLIVOLTS. EPISODES WERE A FAIRLY NEW ONSET. A DEFIBRILLATION THRESHOLD (DFTS) TESTING WAS DONE AT 1.5 MILLIVOLTS, DURING WHICH WAS OBSERVED SOME RARE UNDERSENSING, AND MINIMAL DROP OUT. A CHEST X-RAY WAS DONE, WHICH REVEALED NO ISSUES. THE BOSTON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE INDICATED THAT THE PATIENT HAD SOME TYPE OF BACTERIAL INFECTION OR AUTO IMMUNE ISSUE THAT WAS POSSIBLY RELATED TO THE PRESENCE OF THE DEVICE SYSTEM, OR PATIENT CONDITION. THERE WAS DISCUSSION ABOUT ADJUSTING THE PHARMACOLOGICAL OPTIONS FOR THIS PATIENT.

    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
    1 323 MO E102| 7122