BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1920074 · Received December 3, 2010

    Report

    Report Number
    1644487-2010-02726
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 4, 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 REPORTED THAT THE VNS PT, WHO WAS INITIALLY IMPLANTED WITH THE DEVICE IN (B)(6) 2010, WAS EXPERIENCING AN INCREASE IN SEIZURE FREQUENCY, ABOVE THE PRE-VNS BASELINE. THE PT'S CAREGIVER INDICATED THAT THE SEIZURES HAVE INCREASED SINCE THE VNS DEVICE WAS PROGRAMMED ON AND THE SEIZURES WERE OCCURRING "ONE AFTER ANOTHER". THE TREATING PHYSICIAN HAD PROGRAMMED THE DEVICE TO 0MA AND THE SEIZURE FREQUENCY BEGAN TO DECREASE. THE PT WAS ALSO EXPERIENCING SEVERE HOARSENESS. AT THE PTS REQUEST, THE VNS DEVICE WAS EXPLANTED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION HAS BEEN REC'D TO DATE. IN ADDITION, GOOD FAITH ATTEMPTS TO OBTAIN THE EXPLANTED DEVICE FOR ANALYSIS ARE UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2738

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention