BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2760938 · Received September 26, 2012

    Report

    Report Number
    1644487-2012-02442
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 19, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED DURING A CLINIC VISIT ON (B)(6) 2012, ON A SYSTEM DIAGNOSTIC TEST, SO THE DEVICE WAS TURNED OFF. THE PATIENT WAS SEIZURE-FREE BEFORE VNS WAS PLACED AND HAS CONTINUED TO BE SEIZURE FREE, SO THERE ARE NO PLANS FOR THE PATIENT TO HAVE A REVISION AT THIS TIME. ALTHOUGH REVISION MAY OCCUR IN THE FUTURE, SURGERY HAS NOT OCCURRED TO DATE. THE PATIENT PRESENTED IN THE CLINIC ON (B)(6) 2012, AND THE MAGNET CURRENT WAS CHANGED TO 1.0MA AT THAT TIME BECAUSE THE PATIENT WAS COMPLAINING OF A SHOCKING SENSATION. DIAGNOSTICS ON (B)(6) 2012 RESULTED IN OKAY RESULTS. NO CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES PRECEDED THE ONSET OF THE SHOCKING SENSATION. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED/CONTRIBUTED TO THE SHOCKING SENSATION, AND IT ONLY OCCURS WITH NORMAL MODE STIMULATION. THE PATIENT FEELS IT IN THE NECK AREA, WITH NO SPECIFIC AREA IN THE NECK MENTIONED. SINCE THE DEVICE WAS TURNED OFF ON (B)(6) 2012, DUE TO HIGH IMPEDANCE, THE PAINFUL STIMULATION HAS CEASED. X-RAYS OF THE PATIENT'S VNS SYSTEM HAVE NOT BEEN TAKEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECIEVED INDICATING THE PATIENT IS BEING REFERRED TO NEUROSURGERY FOR EXPLANT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 7732

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR