BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1623698 · Received March 4, 2010

    Report

    Report Number
    1644487-2010-00505
    Event Type
    Injury
    Date Received
    March 4, 2010
    Date of Event
    January 1, 2002
    Report Date
    February 4, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE REFERENCE: MARTIN ORTLER, CLAUDIA UNTERHOFER, JUDITH DOBESBERGER, EDDA HABERLANDT, EUGEN TRINKA. "COMPLETE REMOVAL OF VAGUS NERVE STIMULATOR GENERATOR AND ELECTRODES." JOURNAL OF NEUROSURGERY: PEDIATRICS, FEB 2010, VOL. 5, NO.2, PAGES 191-194.

    Description of Event or Problem · 1

    DURING THE REVIEW OF AN ARTICLE TITLED "COMPLETE REMOVAL OF VAGUS NERVE STIMULATOR GENERATOR AND ELECTRODES", IT WAS NOTED THAT ONE PT EXPERIENCED NO IMPROVEMENT IN SEIZURE CONTROL WITH VNS THERAPY. THE DEVICE REMAINED IMPLANTED IN THE PT FOR 40 MONTHS WITH NO SUCCESS. THE PT'S CAREGIVERS INDICATED THAT "STIMULATION PROVOKED SEIZURES," THEREFORE, THE INCREASE IS PERCEIVED TO BE ABOVE PRE-VNS BASELINE LEVEL. THE DEVICE WAS EXPLANTED DUE TO THE REPORTED LACK OF EFFICACY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PRIMARY AUTHORS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention