BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMIPULSE GEN MODEL 103

    MDR report key: 1943832 · Received December 28, 2010

    Report

    Report Number
    1644487-2010-02897
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 30, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PHYSICIAN AT THE HOSPITAL THAT THE PT WAS EXPERIENCING PAINFUL STIMULATION AT THE ELECTRODE SITE. DEVICE WAS CHECKED AND CONFIRMED TO BE FUNCTIONING WITHIN NORMAL LIMITS. AFTER LOWERING THE SETTINGS, THE PT WAS DOING FINE. FOLLOW UP WITH THE TREATING PHYSICIAN REVEALED THAT THE DEVICE WAS TURNED OFF AS PT'S PAIN WAS NOT RESOLVED AFTER REDUCING THE VNS SETTINGS. PT DID WELL INITIALLY BUT THE EVENT CAME BACK. THE PT REQUESTED TO HAVE THE DEVICE TURNED OFF AS HE COULD NOT TOLERATE THE PAIN AND HE WAS REFERRED TO THE SURGEON FOR A POSSIBLE REVISION SURGERY. PER PHYSICIAN, THE PAIN WAS QUITE SERIOUS FOR THE PT AND THEREFORE, HE HAD TO REFER THE PT FOR A REVISION OF VNS. SURGERY HAS NOT BEEN PLANNED AT THE MOMENT BUT IT WILL LIKELY TAKE PLACE. THE PAIN OCCURS WITH VNS STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEMIPULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200969

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention