BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3233598 · Received July 18, 2013

    Report

    Report Number
    1644487-2013-02172
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 9, 2012
    Report Date
    June 26, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 CLINIC NOTES WERE RECEIVED DATED MAY 9, 2012 THAT INDICATED THE PATIENT HAS NOT NOTED ANY CHANGE IN HIS SEIZURE FREQUENCY OR SEVERITY BUT THE PATIENT¿S FATHER THINKS THAT THE SEIZURES ARE MORE SEVERE LATELY. IT WAS STATED THAT THE PATIENT¿S MEDICATIONS HAD BEEN ADJUSTED AND THE AMPERAGE ON THE VNS WAS RECENTLY TURNED UP HIGHER. THE PATIENT HAD A FALL THAT CUT HIS EYE AND LANDED HIM IN THE ER. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN MADE BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE PHYSICIAN.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED WHICH INDICATED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013 DUE TO "BATTERY DEPLETION". THE EXPLANTING FACILITY DOES NOT RETURNED EXPLANTED PRODUCTS FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334631 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 014865

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other