BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3132031 · Received May 29, 2013

    Report

    Report Number
    1644487-2013-01599
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    March 15, 2013
    Report Date
    May 3, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: NEW INFORMATION IDENTIFIED WHEN THE EVENTS STARTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT SINCE BEING IMPLANTED (B)(6) 2013 PRESENTED WITH DROWSINESS, WITH NAUSEA, VOMITING, ANOREXIA, ASPIRATION WHEN FEEDING FROM THE IMPLANT. NO RHYTHMICITY DEPENDING ON THE FREQUENCY OF STIMULATION. THE PATIENT THERAPY HAS BEEN TITRATED PER THEIR STUDY PROTOCOL. THE PATIENT HAD PERSISTENCE OF THEIR SYMPTOMS THE PARENTS CONTACTED THE SURGEON, WHO OFFERED TO TEMPORARILY STOP THEIR THERAPY TO SEE IF THERE WOULD BE IMPROVEMENT AND CHECK RELATIONSHIP TO THEIR DEVICE. SYMPTOMS PARTIALLY REGRESSED BETWEEN (B)(6). THEY DISABLED THEIR DEVICE ON (B)(6), AND STARTED AGAIN WITH MODIFIED SETTINGS (B)(6) THE 2013. IN THE MEANTIME, NO CHANGE IN SYMPTOMS. THEIR FOLLOWING PHYSICIAN DOES NOT THINK THAT THE SYMPTOMS ARE RELATED TO THE STIMULATION, PROVIDED THAT THE PATIENT HAS SINCE DEVELOPED A COLD SORE AND FEVER. ONLY FOOD-INITIAL ASPIRATIONS ARE POTENTIALLY LINKED, IN THEIR OPINION. NO CHANGE IN MEDICATION WAS REPORTED AND NO MEDICINAL TREATMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENTS RESOLVED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234538 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 3467

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other