BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3802242 · Received May 9, 2014

    Report

    Report Number
    1644487-2014-01232
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 11, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT IS EXPERIENCING AN INCREASE IN SEIZURES AND THAT THE GENERATOR BATTERY IS LOW. THE NOTES INDICATE THAT THE PATIENT IS BEING PLANNED FOR GENERATOR REPLACEMENT. CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT HAS NOT BEEN SEEN IN ABOUT FIVE TO SIX YEARS. IT WAS NOTED THAT THE PATIENT REMAINS OFF ALL SEIZURE MEDICATIONS AND THAT THE PATIENT CAN FEEL THE GENERATOR BATTERY IS WEAKENING. IT WAS ALSO NOTED THAT THE PATIENT HAS NOTED AN INCREASE IN NIGHT SEIZURES. THE NOTES INDICATE THAT THE PATIENT HAS ABOUT THREE OR FOUR CONVULSION DURING THE DAY PER MONTH AND AT NIGHT, THE PATIENT IS HAVING AN UNKNOWN NUMBER OF SEIZURES PER MONTH. IT WAS NOTED THAT THE PATIENT AGREED THAT THE WEAKENING GENERATOR BATTERY COULD BE THE CAUSE OF THE NOCTURNAL SEIZURES, BUT THAT IT COULD ALSO BE DUE TO HIS HIGH USE OF BENADRYL. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. THE EXPLANTING FACILITY DOES NOT RETURN EXPLANTED DEVICES FOR ANALYSIS; THEREFORE NO ANALYSIS CAN BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280880 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R 011252

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention