BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3083256 · Received April 29, 2013

    Report

    Report Number
    1644487-2013-01195
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    January 1, 1999
    Report Date
    April 2, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT'S DEVICE HAD BEEN PROGRAMMING OFF SINCE 1999 BECAUSE IT MADE THE PATIENT'S SEIZURES OCCUR FROM BOTH SIDES OF THE PATIENT'S BRAIN AND IT DID NOT IMPROVE HIS SEIZURES. THE PATIENT'S MOTHER ALSO INDICATED THAT THE PATIENT HAS NOT BEEN SEEING A NEUROLOGIST. THE PATIENT'S GASTROENTEROLOGIST REPORTED THAT THE MOTHER REPORTED THAT THE DEVICE WAS DISABLED A WHILE BACK; HOWEVER, SHE ADDED THAT THERE WAS A POSSIBILITY OF THE DEVICE STILL STIMULATION. IT WAS ALSO REPORTED THAT THE MOTHER CLAIMS THE DEVICE HAS MIGRATED OFF OF THE NERVE AND THINKS THIS IS THE CASE JUST BY FEELING IT; HOWEVER, THE GASTROENTEROLOGIST EXPLAINED THAT THE PATIENT HAS A STIFF NECK DUE TO HIS OTHER HEALTH PROBLEMS AND PERHAPS THIS COULD BE CONTRIBUTING TO WHAT THE MOTHER IS FEELING WHEN SHE PALPATES THE PATIENT'S NECK. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185826 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention