BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 3941814 · Received July 17, 2014

    Report

    Report Number
    1644487-2014-01768
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GENERATOR WAS COMPLETED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE RETURNED GENERATOR SHOWED AN IFI CONDITION. MONITORING OF THE DEVICE OUTPUT SIGNAL SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    INITIALLY IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SLIGHT INCREASE IN SEIZURES AND WAS REFERRED FOR GENERATOR REPLACEMENT. CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT¿S MOTHER REPORTS THAT THE PATIENT¿S SEIZURES ARE SLIGHTLY WORSE, BUT MANAGEABLE AND MOSTLY OCCUR IN THE SETTING OF NAPS. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A CHRONIC SEIZURE STATE AND GENERATOR REPLACEMENT WAS MOVED UP. THE PATIENT UNDERWENT GENERATOR REPLACEMENT. THE EXPLANTED GENERATOR HAS BEEN RECEIVED AND INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419782 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 3220

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention