BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2133431 · Received June 15, 2011

    Report

    Report Number
    1644487-2011-01332
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT SHE WAS HAVING PAIN IN THE NECK AREA AROUND WHERE THE GENERATOR WAS IMPLANTED. THE PT EXERTS HERSELF QUITE FREQUENTLY, AND THE PAIN STARTED APPROX 3 WEEKS PRIOR. THE DEVICE HAD BEEN DISABLED 8 YEARS AGO AS SHE BECAME SEIZURE-FREE AT THAT TIME. THE PT WAS TO HAVE A CONSULT FOR THE POSSIBLE REMOVAL OF HER DEVICE. THE PT SUBSEQUENTLY UNDERWENT A FULL EXPLANT SURGERY. THE PRODUCT HAS BEEN REC'D FOR EVAL, THOUGH IT HAS NOT BEEN COMPLETED TO DATE. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 1862

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R