BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1872833 · Received October 14, 2010

    Report

    Report Number
    1644487-2010-02295
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 17, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT WAS HAVING INCREASED SEIZURES. THE PT'S VNS WAS AT END OF SERVICE = YES, BUT IT IS NOT KNOWN IF THIS IS THE CAUSE OF THE SEIZURE INCREASE. THE PT LATER HAD GENERATOR REPLACEMENT SURGERY DUE TO BATTERY DEPLETION. THE EXPLANTED GENERATOR HAS BEEN RETURNED AND IS CURRENTLY IN PRODUCT ANALYSIS. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS INC 101 5692

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention