BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2070196 · Received April 25, 2011

    Report

    Report Number
    1644487-2011-00893
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    March 26, 2007
    Report Date
    March 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED INDICATING A VNS PATIENT HAD WORSENING SEIZURES IN (B)(6) 2007. KEPPRA MEDICATION WAS ADDED AS AN INTERVENTION FOR THE SEIZURES. THE PATIENT RECENTLY HAD VNS GENERATOR REPLACEMENT SURGERY DUE TO REPORTED END OF SERVICE. ATTEMPTS FOR FURTHER INFORMATION AND RETURN OF THE EXPLANTED VNS GENERATOR ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 1671

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention