BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1132604 · Received August 21, 2008

    Report

    Report Number
    1644487-2008-01980
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 29, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INITIALLY INDICATED A VNS PT WAS HOSPITALIZED AND THAT THE VNS WAS BELIEVED TO HAVE A DEPLETED BATTERY. THE VNS WAS LATER FOUND TO NOT BE AT END OF SERVICE AND "TESTED FINE". ALL ATTEMPTS TO THE REPORTER REGARDING THE REASON FOR THE PATIENT'S HOSPITALIZATION AND ADDITIONAL INFO 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 8861

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention