BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMIPULSE GEN MODEL 103

    MDR report key: 1943812 · Received December 28, 2010

    Report

    Report Number
    1644487-2010-02903
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    October 1, 2010
    Report Date
    December 5, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT THE PT WAS RECENTLY IMPLANTED AND EXPLANTED DUE TO INCREASE IN SEIZURE ACTIVITY. PT WAS HOSPITALIZED DUE TO INCREASE SEIZURES AND THEN HAD HIS VNS EXPLANTED. NO PT INFO WAS PROVIDED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEMIPULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention