BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2173763 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11116
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACING SYSTEM REMAINS IMPLANTED. A BOSTON SCIENTIFIC TECHNICAL SERVICE CONSULTANT REVIEWED THE SAVE TO DISK AND DISCUSSED THAT IT APPEARS THAT THERE COULD BE A LEAD CONNECTION ISSUE. THE DEVICE WAS IMPLANTED IN (B)(6) 2010. SOME ACUTE CHANGES IN RV IMPEDANCE MEASUREMENT COULD BE NOTED AT THE END OF (B)(6) 2010. THROUGHOUT THE ENTIRE YEAR OF DATA, SOME OUT-OF-RANGE MEASUREMENTS (>2,000 OHMS) WERE RECORDED.BASELINE MEASUREMENTS APPEAR TO BE AROUND 450 OHMS, HOWEVER, IMPEDANCE WAS MEASURED A COUPLE OF TIMES WITH "OUT-OF-THE-TREND" VALUES. THE CHANGES IN MEASUREMENT WERE FOR ONE DAY TO THE OTHER AND WERE NOT PART OF A MORE GLOBAL TREND EVOLUTION. DEPENDING ON PATIENT POSITION DURING THE DAILY MEASUREMENT, POOR CONTACT COULD HAVE OCCURRED AND CONTRIBUTED TO AN OUT-OF-RANGE MEASUREMENT. A REVIEW OF THE ARRHYTHMIA LOGBOOK REVEALED NSVT EPISODES RECORDED BY THE DEVICE AS WELL AS TWO VF EPISODES. THE NOISE PATTERN IS LIKELY INDICATIVE OF A POOR CONNECTION CONTACT. FURTHER TROUBLESHOOTING COULD INCLUDE AN X-RAY PICTURE IN ORDER TO CONFIRM THAT THE LEAD IS FULLY INSERTED AND THAT THE SET SCREWS ARE FULLY TIGHTENED. A FULL ASSESSMENT OF LEAD INTEGRITY WAS ALSO RECOMMENDED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND COMPETITOR RIGHT VENTRICULAR DEFIBRILLATION LEAD EXHIBITED A FEW SHORT EPISODES OF PACING IMPEDANCES GREATER THAN 2,000 OHMS AND NOISE. MECHANICAL MANIPULATIONS WERE PERFORMED, HOWEVER, NONE OF THE OUT OF RANGE MEASUREMENTS OR NOISE COULD BE REPRODUCED. FOLLOW-UP VALUES WERE NORMAL. THE PATIENT ALSO MENTIONED THAT HE USES ELECTRICAL, BATTERY OPERATED DRILLS IN HIS WORK. THE DURATION OF THE VF ZONE WAS INCREASED TO 5.0 SECONDS IN ORDER TO AVOID INAPPROPRIATE SHOCKS AND THE PACING SYSTEM REMAINS IMPLANTED. A SAVE TO DISK WAS SENT TO BOSTON SCIENTIFC TECHNICAL SERVICES FOR REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MISMATCH| F110