BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1001064 · Received February 22, 2008

    Report

    Report Number
    1644487-2008-00371
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER THAT THE PATIENT'S DEPRESSION WAS WORSENING. FURTHER INVESTIGATION REVEALED THAT THE REPORTED CONDITION STARTED FOUR DAYS AFTER VNS IMPLANTATION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other