BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1961089 · Received January 12, 2011

    Report

    Report Number
    1644487-2011-00043
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    November 29, 2010
    Report Date
    December 13, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES RECEIVED THAT THE PT WAS EXPERIENCING AN INCREASE IN NOCTURNAL SEIZURES AND WAS BEING REFERRED FOR A PROPHYLACTIC BATTERY CHANGE. IT WAS NOTED THAT THE PT'S VNS HAD NOT BEEN CHECKED IN TWO YEARS. NO CHANGE IN MEDICATION OR OTHER FACTORS WERE NOTED AS POSSIBLE CONTRIBUTORS. IT WAS ALSO NOTED THAT THE PT WAS RECENTLY EXPERIENCING SLEEP APNEA; HOWEVER, THE RELATIONSHIP TO VNS IS UNK. THE PT'S VNS GENERATOR HAS BEEN REPLACED. ATTEMPTS FOR THE RETURN OF THE EXPLANTED GENERATOR ARE CURRENTLY IN PROGRESS. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS INC 101 5549

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention