BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1184419 · Received October 2, 2008

    Report

    Report Number
    1644487-2008-02394
    Event Type
    Injury
    Date Received
    October 2, 2008
    Date of Event
    June 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A VNS PATIENT REPORTED THAT HER VNS DEVICE HAD BEEN PROGRAMMED OFF, BUT SHE WAS STILL HAVING PAIN IN THE NECK AREA. THE PATIENT INDICATED SHE WAS TRYING TO FIND A SURGEON TO EXPLANT THE DEVICE. FOLLOWUP WITH THE PATIENT'S TREATING PHYSICIAN REVEALED THAT HER VNS DEVICE HAD BEEN REMOVED A LONG TIME AGO. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention