BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1834541 · Received September 10, 2010

    Report

    Report Number
    1644487-2010-02075
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT THE VNS PT'S DEVICE COULD NOT BE INTERROGATED. NOTES WERE RECEIVED FROM THE OFFICE IN WHICH THE PT WAS INDICATED TO HAVE EXPERIENCED AN INCREASE IN SEIZURE ACTIVITY SINCE 2008. FOLLOW-UP REVEALED THAT THE INCREASE WAS NOT RELATED TO VNS THERAPY AS THE THERAPY HAS PROVEN BENEFICIAL FOR THE PT'S SEIZURE ACTIVITY. THE CAUSE OF THE INCREASE IS MOST LIKELY DUE TO STRESS OR OTHER EXTERNAL FACTORS. IT WAS ALSO INDICATED THAT THE PT'S DEVICE WAS BELIEVED TO BE AT END OF SERVICE SINCE THE PROGRAMMING SYSTEM FUNCTIONED PROPERLY WITH OTHER PT'S DEVICES. A BATTERY LIFE CALCULATION HAS BEEN PERFORMED ON THE PT'S DEVICE THAT REVEALED THE DEVICE IS MOST LIKELY AT END OF SERVICE. DIAGNOSTIC TESTS PERFORMED DURING (B)(6) 2009 WERE WITHIN NORMAL LIMITS. THE REPORTED INCREASE IN SEIZURES EVENT HAS BEEN DETERMINED TO BE UNRELATED TO VNS THERAPY. THE GENERATOR'S SUSPECTED END OF SERVICE CONDITION IS MOST LIKELY THE ROOT CAUSE FOR THE REPORTED FAILURE TO PROGRAM EVENT. IT WAS LATER NOTED THAT DURING THE GENERATOR REPLACEMENT SURGERY, THE PT'S LEAD WAS NOTED TO NO LONGER BE ON THE NERVE, SO A FULL REVISION WAS PERFORMED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO ARE IN PROGRESS. THE EXPLANTED DEVICE WAS SAID TO NOT BE RETURNED TO THE MFR FOR ANALYSIS AS IT HAS BEEN DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 8521

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR