BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1051737 · Received May 23, 2008

    Report

    Report Number
    1644487-2008-01217
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT WAS HOSPITALIZED FOR A PROLONGED PERIOD DUE TO SUICIDE PREVENTION. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 016250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R