BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2170956 · Received June 30, 2011

    Report

    Report Number
    1644487-2011-01476
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    December 2, 2010
    Report Date
    June 2, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF THE IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO ANOMALIES NOTED. DEVICE FAILURE SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS HAD AN INCREASE IN SEIZURES, SAME AS PRE-VNS BASELINE FOR AWHILE. SYSTEM DIAGNOSTICS WERE PERFORMED AND INITIALLY GAVE DC/DC CODE = 2. THEY WERE PERFORMED AGAIN AND GAVE DC/DC CODE = 0. THE PHYSICIAN TESTED SEVERAL TIMES IN DIFFERENT PT POSITIONS AND THE DC/DC CODE FLUCTUATED BETWEEN 0 AND 2, BUT THE LAST FEW STAYED AT DC/DC CODE = 2. PER PT, STIMULATION IS PERCEIVED MORE WHEN PT IS LAYING ON LEFT SIDE. PT'S SETTINGS WERE CHANGED AT THE END OF THE VISIT. AT THIS TIME NO INTERVENTIONS ARE PLANNED, BUT PT WILL BE MONITORED. PT IS NOT EXPERIENCING ANY PAINFUL OR ERRATIC STIMULATION. X-RAYS WERE SENT TO THE MFR FOR REVIEW AND NO ANOMALIES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1921

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR