BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1229990 · Received November 12, 2008

    Report

    Report Number
    1644487-2008-02736
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 13, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEUROSURGEON WANTED TO TURN OFF A PATIENT'S VNS DEVICE SO THAT HE COULD TREAT THE PATIENT'S SYNCOPE AND ORTHOSTATIC HYPOTENSION. THE RELATIONSHIP BETWEEN THE PATIENT'S CONDITIONS AND THE DEVICE IS UNKNOWN AT THIS TIME, AS GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION 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 012081

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention