BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4151717 · Received October 8, 2014

    Report

    Report Number
    1644487-2014-02581
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S SEIZURES OFTEN FLUCTUATE AND THAT THIS EVENT IS NORMAL FOR THE PATIENT. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTING FACILITY WILL NOT RETURN EXPLANTED DEVICES TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, NO ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED INDICATING THAT THE VNS PATIENT RECENTLY EXPERIENCED AN INCREASE IN SEIZURES AND THAT THE PATIENT¿S MAGNET WAS NOT EFFECTIVE IN ABORTING SEIZURES. THE NOTES SUGGEST THAT THE PATIENT¿S DEVICE WAS AT END OF SERVICE BUT IT IS UNCLEAR WHETHER THE DEVICE WAS ACTUALLY AT END OF SERVICE. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY SHOWED APPROXIMATELY 0.1 YEARS UNTIL END OF SERVICE. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. NO FURTHER INFORMATION RELEVANT TO THE EVENT HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633588 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201860

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention