BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2160774 · Received July 7, 2011

    Report

    Report Number
    1644487-2011-01525
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    June 7, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES RECEIVED THAT THE VNS PATIENT HAS BEEN EXPERIENCING SLEEP APNEA. THE RELATIONSHIP OF THE PATIENT'S SLEEP APNEA TO VNS THERAPY IS UNKNOWN AT THIS TIME. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 11989

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening