BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2000221 · Received February 17, 2011

    Report

    Report Number
    1644487-2011-00284
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST THAT A VNS PT HAD AN INCREASE IN SEIZURE AND SWIPING THE MAGNET DOES NOT WORK FOR HIM ANYMORE. THE PT IS NON VERBAL AND SEVERELY IMPAIRED. THE NEUROLOGIST REFERRED THE PT FOR PROPHYLACTIC GENERATOR REPLACEMENT. THE PATIENT'S DIAGNOSTIC SETTINGS PRIOR TO SURGERY WERE WITHIN NORMAL LIMIT. IT IS UNK IF PATIENT'S INCREASE SEIZURES WERE ABOVE OR BELOW PRE-VNS BASELINE. GOOD FAITH ATTEMPTS TO OBTAIN MORE INFO REGARDING VNS PT HAS BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 015424

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention