BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2190283 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01661
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2007
    Report Date
    June 22, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD OVER 300 SEIZURES (PER PT MOTHER) THE DAY PRIOR TO A CORPUS CALLOSOTOMY IN 2007. SINCE THAT TIME, HIS SEIZURES HAVE BEEN UNDER BETTER CONTROL. IT IS UNK IF THIS SPIKE WAS RELATED TO VNS OR THE RELATIONSHIP TO HIS PRE-VNS BASELINE. THE GENERATOR HAD BEEN EXPLANTED DUE TO REPORTED END OF SVC AND HAD BEEN RETURNED TO THE MFR PREVIOUSLY. THE REPORTED END OF SVC CONDITION WAS DUPLICATED IN THE PRODUCT ANALYSIS LAB AND WAS DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY DEPLETION AND THE PULSE GENERATOR MODULE IS OPERATING WITHIN DESIGNED LIMITS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. 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 009206

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention