BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1901643 · Received November 12, 2010

    Report

    Report Number
    1644487-2010-02564
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    March 1, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THROUGH CLINIC NOTES THAT THE PT WAS HAVING INCREASE IN SEIZURES OVER THE LAST SIX MONTHS. PHYSICIAN STATED THAT HE BELIEVES RIGHT NOW THE MAIN REASON FOR BREAKTHROUGH SEIZURES IS DUE TO END OF LIFE. IT SEEMED FROM THE NOTES THAT THE PHYSICIAN WAS NOT SURE ABOUT THE REASON FOR INCREASE 6 MONTHS AGO. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TILL DATE. PT UNDERWENT A BATTERY REPLACEMENT SURGERY DUE TO END OF SERVICE. END OF SERVICE FLAG WAS CONFIRMED IN THE OPERATING ROOM. EXPLANTED GENERATOR WAS RETURNED TO MANUFACTURER FOR ANALYSIS. ANALYSIS IS CURRENTLY PENDING ON THE EXPLANTED GENERATOR. DIAGNOSTICS ON THE NEW GENERATOR SHOWED EVERYTHING WORKING WITHIN NORMAL LIMITS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention