BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL102

    MDR report key: 2201793 · Received August 5, 2011

    Report

    Report Number
    1644487-2011-01785
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    August 1, 2010
    Report Date
    July 12, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN WAS TURNING THE PATIENT OFF TEMPORARILY. THE PATIENT HAD A GI TUMOR NOT RELATED TO VNS AND HAD LOST A LOT A WEIGHT DUE TO IT. THE PATIENT IS NOW HAVING TROUBLE PUTTING THE WEIGHT BACK ON. SINCE THE VAGAL NERVE GOES TO THE GI TRACT THEY ARE GOING TO TRY TO DISABLE THE PATIENT FOR A SHORT TIME TO SEE IF THAT WILL HELP HIM GAIN WEIGHT. THEY DO NOT FEEL THAT THE VNS IS CAUSING THE LACK OF WEIGHT GAIN BUT WANT TO SEE IF DISABLING VNS MAY HELP WITH THE WEIGHT GAIN. THE GASTROPARESIS REPORTED BY THE PATIENT WAS DETERMINED TO BE RELATED TO THE GI TUMOR AND THE RESULTING WEIGHT LOSS, BOTH OF WHICH WERE NOT RELATED TO VNS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD BEEN EXPERIENCING GASTROINTESTINAL ISSUES. THE PT ALLEGED THAT VNS WAS CAUSING GASTROPARESIS AND CAUSING HIS GASTROINTESTINAL ISSUES HOWEVER HIS PHYSICIAN DID NOT INDICATE THAT. THE PT IS CONSIDERING HAVING HIS VNS REMOVED ALTHOUGH THERE ARE CURRENTLY NO PLANS FOR THAT. GOOD FAITH ATTEMPTS FOR MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL102 MUZ CYBERONICS, INC. 102 016066

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention