BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1901618 · Received November 12, 2010

    Report

    Report Number
    1644487-2010-02538
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    July 1, 2010
    Report Date
    October 15, 2010
    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 IN CLINIC NOTES THAT THE PATIENT'S SEIZURES WERE MORE PROLONGED, UNK IF ABOVE OR BELOW BASELINE. PATIENT HAD A RECENT GENERATOR REPLACEMENT. A BATTERY LIFE CALCULATION FOR THE GENERATOR INDICATED THAT IT WAS AT END OF SERVICE. IT IS UNK IF THE CHANGE IN SEIZURE PATTERN WAS RELATED TO THE GENERATOR BEING AT END OF SERVICE. THE GENERATOR HAS NOT BEEN RETURNED TO THE MFR TO DATE. GOOD FAITH ATTEMPTS TO GAIN ADD'L INFO HAS BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 102 200809

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention