BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3232870 · Received July 18, 2013

    Report

    Report Number
    1644487-2013-02165
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 17, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 WERE RECEIVED ON (B)(4) 2013. THE NOTES INDICATED THAT THE PATIENT HAS NOT HAD ANY EPISODES CONCERNING FOR SEIZURES EVEN AFTER A MEDICATION CHANGE TO GENERIC LAMICTAL. THE PATIENT HAD HIS LAST SEIZURE ON (B)(6) 2012 BUT HAS HAD SOME MINOR WORSENING IN SEIZURE FREQUENCY. THE PATIENT DID NOT REPORT ANY MEDICATION-RELATED SIDE EFFECTS. THE PATIENT¿S DEVICE WAS INTERROGATED, AND A MAGNET MODE DIAGNOSTIC WAS WITHIN NORMAL LIMITS. THE DEVICE REPORTEDLY HAD APPROXIMATELY 25% OF BATTERY REMAINING. THE PATIENT EXPERIENCED MODERATE PAIN IN THE NECK WITH MAGNET SWIPES. AN IMPLANT CARD INDICATED THAT THE PATIENT UNDERWENT GENERATOR REVISION ON (B)(6) 2013 DUE TO NEOS=YES. THE EXPLANTED PRODUCT IS NOT EXPECTED FOR RETURN PER HOSPITAL POLICY.

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE PHYSICIAN SHOWED THAT THE PATIENT ACTUALLY DID NOT EXPERIENCE AN INCREASE IN SEIZURES: THIS WAS MISWRITTEN IN THE NOTES. THE PATIENT UNDERWENT GENERATOR REVISION DUE TO END OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335123 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201065

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other