BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2052676 · Received April 7, 2011

    Report

    Report Number
    1644487-2011-00741
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    January 1, 2007
    Report Date
    March 8, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE MOTHER OF THE VNS PT THAT THE PT BEGAN EXPERIENCING SLEEP APNEA, AMBULATION DIFFICULTIES, PAINFUL STIMULATION IN THE CHEST, DIZZINESS, FLUSHING IN THE FACE, DYSPEPSIA, AND INCREASE IN SEIZURES ABOVE BASELINE ABOUT 3-4 YEARS AGO BUT WAS UNSURE OF THEIR RELATIONSHIP TO VNS. ATTEMPTS TO FURTHER INFO FROM THE PT'S PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE. NO DEVICE FAILURE IS SUSPECTED. IT HAS BEEN NOTED THAT SURGERY TO REPLACE THE PT'S GENERATOR PROPHYLACTICALLY IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 012830

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening| R