BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2072371 · Received April 8, 2011

    Report

    Report Number
    1644487-2011-00759
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES THAT THE PT WAS EXPERIENCING SOME INCREASE IN SEIZURES IN (B)(6) 2011. IN (B)(6) 2011, THE PT HAD A SEIZURE THAT WAS MORE PROLONGED THAN NORMAL. IT WAS ALSO NOTED THAT THE MAGNET WAS NOT ABORTING SEIZURES AS IT USED TO AND THE PT DID NOT FEEL LIKE THE VNS WAS WORKING AS WELL. THE PT'S SETTINGS WERE ADJUSTED, AND THE PT MAY BE REFERRED FOR A GENERATOR REPLACEMENT. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 015227

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other