BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1150385 · Received September 4, 2008

    Report

    Report Number
    1644487-2008-02152
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 7, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED TO MANUFACTURING CASE MANAGER THAT "HER GI DR. RECOMMENDS SHE HAS THE VNS REMOVED. SHE HAS HAD PROBLEMS WITH DIFFICULTY SWALLOWING AND ACID REFLUX(BEFORE VNS AS WELL) AND HAS HAD TO HAVE HER ESOPHAGUS STRETCHED LAST MONTH AND YESTERDAY. HER GI DR. TOLD HER BECAUSE THE VNS STIMULATES THE VAGUS NERVE, IT IS INCREASING HER GI PROBLEMS. SHE FEELS WORSE TODAY THAN SHE DID 2 YRS AGO WHEN SHE HAD VNS PLACED." THE PATIENT WILL BE GOING BACK TO HER TREATING PHYSICIAN TO DISCUSS HAVING THE VNS ADJUSTED OR REMOVED. THE VNS WAS REPORTED TO NOT HELP THE PT WITH THEIR DEPRESSION. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL INFO ABOUT THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 013476

    Patients

    Seq Age Sex Outcome Treatment
    1 Other