BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2190786 · Received July 26, 2011

    Report

    Report Number
    1644487-2011-01680
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT WAS TAKEN TO THE EMERGENCY ROOM AFTER EXPERIENCING A GRAND MAL SEIZURE AND WAS ADMITTED AFTER HAVING ANOTHER SEIZURE WHILE IN THE EMERGENCY ROOM. THE GENERATOR WAS FOUND TO BE AT END OF SERVICE AT THAT TIME. THE GENERATOR WAS REPLACED AND WAS RETURNED TO THE MFR FOR EVAL. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. CLINIC NOTES WERE RECEIVED INDICATING THAT THE PT ALSO HAD AN INCREASE IN SEIZURES A FEW MONTHS PRIOR, UNK IF ABOVE OR BELOW BASELINE. THE PHYSICIAN WAS IN THE PROCESS OF ADJUSTING MEDICATIONS. THE PT HAS ALSO BEEN HOSPITALIZED IN THE PAST FOR PSYCHIATRIC ISSUE, UNK IF RELATED TO VNS. GOOD FAITH ATTEMPTS FOR MORE 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 016066

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention