BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2942023 · Received February 4, 2013

    Report

    Report Number
    1644487-2013-00280
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 22, 2012
    Report Date
    January 11, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE REOCCURRENCE OF GRAND MAL SEIZURE WAS NOT RELATED TO VNS. THE PHYSICIAN NOTED THAT THERE WAS NO CHANGE AND IT WAS WORKING. THERE HAD BEEN NO SETTINGS CHANGES PRIOR TO (B)(6) 2013. SETTINGS WERE ADJUSTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS VNS PATIENT REPORTED THAT, AROUND THANKSGIVING TIME, SHE BEGAN TO HAVE GRAND MAL SEIZURES AGAIN AFTER NOT HAVING HAD THEM FOR SEVERAL YEARS. THE PATIENT BELIEVED IT MAY HAVE HAD SOMETHING TO DO WITH THE MAGNET. THE PATIENT WAS SEEN BY HER NEUROLOGIST ON (B)(6) /2013 AND SETTINGS WERE INCREASED: PRIOR TO THIS APPOINTMENT, THE PATIENT'S SETTINGS HADN'T BEEN CHANGED; THERE WERE NO RECENT MEDICATION CHANGES; AND THERE WERE NO OTHER EXTERNAL CHANGES OR TRAUMA. THE PATIENT BELIEVED THE GM SEIZURES MAY HAVE BEEN DUE TO THE STRESS OF THE HOLIDAYS BUT COULD NOT VERIFY. THE PATIENT ALSO INDICATED THAT SHE COULD NOT PERCEIVE NORMAL STIMULATION. THE DEVICE WAS CHECKED AT THE APPOINTMENT WITH NORMAL BATTERY STATUS. A BATTERY LIFE CALCULATION PERFORMED INDICATED 6.65 YEARS REMAINING. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46737 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 014818

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR