BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1944785 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-21231
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 7, 2010
    Report Date
    November 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT REPROGRAMMING WAS AGAIN REQUIRED FOR OPTIMIZATION. THE PATIENT WAS ALSO PROVIDED WITH A REMOTE MONITORING SYSTEM SO AS TO PROVIDE THE PHYSICIAN WITH REAL TIME EPISODE INFORMATION. NOISE REDUCTION EXPECTED FOLLOWING THIS MOST RECENT PROGRAMMING CHANGE. NO ADVERSE EFFECTS REPORTED AND ALL PRODUCTS REMAIN IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE SENSITIVITY WAS REPROGRAMMED. NO FURTHER OVERSENSING WAS NOTED AFTER THE REPROGRAMMING. 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE HAD DETECTED NOISE ON THE PACE/SENSE AND SHOCK CHANNELS. THE NOISE COULD BE REPRODUCED WHEN THE PATIENT CHANGED POSTURE. THE NOISE WAS OVERSENSED, LEADING TO PACING INHIBITION WITH PERIODS OF ASYSTOLE GREATER THAN TWO SECONDS. AN X-RAY WAS PERFORMED, AND IT WAS NOTED THE PACE/SENSE LEAD WAS VERY CLOSE TO THE DEFIBRILLATION LEAD. 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 F102

    Patients

    Seq Age Sex Outcome Treatment
    1 F102| 0185