BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1040264 · Received May 7, 2008

    Report

    Report Number
    1644487-2008-01086
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    October 1, 2007
    Report Date
    April 16, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THE PT WAS HAVING AN INCREASE IN SEIZURE ACTIVITY, BELOW PRE-VNS BASELINE, NORMAL STIMULATION WAS NOT BEING PERCEIVED, AND THE PT REPORTED PAIN IN THE CHEST AREA. THE CAUSE OF CHEST PAIN / INCREASED SEIZURES IS UNKNOWN. NO DEVICE ISSUES ARE SUSPECTED TO HAVE CONTRIBUTED TO PT'S STIMULATION NOT PERCEIVED EVENT. ALL DIAGNOSTIC TESTING WAS WITHIN NORMAL LIMITS AND THE GENERATOR WAS NOT AT OR NEARING END OF BATTERY LIFE. IT IS LIKELY THAT THE PT ACCOMMODATED TO NORMAL MODE SETTINGS AS THE PATIENT WAS ABLE TO FEEL MAGNET MODE STIMULATION. THE PT HAD A PROPHYLACTIC GENERATOR REPLACEMENT. IT WAS ADDITIONALLY REPORTED FROM THE EXPLANTING HOSP THAT IT WAS REPLACED FOR PAIN AND MIGRATION. THE MIGRATION WAS NOT CONFIRMED FROM THE SURGEON WHO DID THE PROCEDURE. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR PRODUCT RETURN AND ADDITIONAL INFO ABOUT THE EVENTS. NO FURTHER INFO HAS BEEN ATTAINED. X-RAYS REVIEWED BY MFR PRIOR TO SURGERY DID NOT SHOW ANY ANOMALIES OR GROSS LEAD FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 1988

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R