BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 1841948 · Received September 21, 2010

    Report

    Report Number
    1644487-2010-02142
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 22, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT WAS EXPERIENCING LOSS OF HEARING ON THE LEFT SIDE. THE PT'S VNS WAS DISABLED AND THE PT HAS BEEN REFERRED TO AN ENT. NO FURTHER DETAILS WERE IMMEDIATELY MADE AVAILABLE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention