BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3022035 · Received March 26, 2013

    Report

    Report Number
    1644487-2013-00822
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 26, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAS 3 PROLONGED SEIZURES SINCE HIS LAST APPOINTMENT AND AN INCREASE IN SEIZURES. THE PHYSICIAN HAS ONLY SEEN THE PATIENT A COUPLE TIMES AND THERE WAS NO ADDITIONAL INFORMATION AVAILABLE FROM THE OFFICE. THE PATIENT HAD A GENERATOR REPLACEMENT AND THE GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. A BATTERY LIFE CALCULATION SHOWED THAT THE PATIENT'S GENERATOR WAS NEAR OR AT END OF SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE DETERMINED THAT THE BATTERY WAS DEPLETED. THE END OF SERVICE CONDITION WAS THE RESULT OF NORMAL, EXPECTED BATTERY DEPLETION BASED ON THE BATTERY LIFE CALCULATION, THE ELECTRICAL TEST RESULTS AND THE BENCH EVALUATION. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE GENERATOR IN THE PRODUCT ANALYSIS LAB CONCLUDED THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124470 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 012081

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR