BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEMIPULSE GENERATORS

    MDR report key: 2201314 · Received August 3, 2011

    Report

    Report Number
    1644487-2011-01769
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT OFF TIME WAS SET TO 10 MINUTES BUT WAS FEELING STIMULATION EVERY 30 SECONDS. THE GENERATOR WAS TEMPORARILY DISABLED AND THE PT CONFIRMED THAT SHE DID NOT FEEL STIMULATION. WHEN THE DEVICE WAS TURNED BACK ON TO PREVIOUS SETTINGS, THE PT AGAIN FELT STIMULATION EVERY 30 SECONDS. DIAGNOSTICS WERE RUN AND WERE WITHIN NORMAL LIMITS. THE PHYSICIAN WANTS TO REPLACE THE GENERATOR, HOWEVER, SURGERY HAS NOT OCCURRED DUE TO INSURANCE ISSUES. GOOD FAITH ATTEMPTS FOR MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEMIPULSE GENERATORS LYJ CYBERONICS, INC. 103 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR