BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1666449 · Received April 22, 2010

    Report

    Report Number
    1644487-2010-00970
    Event Type
    Injury
    Date Received
    April 22, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 23, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT THE PT DID NOT HAVE AN INCREASE IN SEIZURES, BUT WAS SLEEPING MORE THAN USUAL. THE PHYSICIAN ORDERED AN EEG, WHICH SHOWED THAT THE PT WAS IN STATUS. ATTEMPTS FOR FURTHER INFO FROM THE PT'S TREATING PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE, THEREFORE, THE RELATIONSHIP BETWEEN THE EVENT AND VNS THERAPY CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 8814

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other