BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 4113667 · Received September 24, 2014

    Report

    Report Number
    1644487-2014-02446
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 27, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRODUCT ANALYSIS ON THE GENERATOR WAS COMPLETED AND APPROVED ON 11/23/2015. AN END-OF-SERVICE WARNING MESSAGE WAS VERIFIED IN THE PA LAB AND FOUND TO BE ASSOCIATED WITH THE OUTPUT BEING DISABLED BY THE PULSE GENERATOR. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE EXPLANT. OTHER THAN THE NOTED EVENT (PULSEDISABLED), THERE WERE NO ADDITIONAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES IN (B)(6) 2014. THE PHYSICIAN SUBSEQUENTLY INCREASED THE PATIENT¿S DEVICE DUTY CYCLE FROM 44% TO 49% WHICH SLIGHTLY DECREASED THE PATIENT¿S SEIZURE FREQUENCY. THE PATIENT AVERAGED 30-40 SEIZURES PER MONTH. THE PATIENT¿S DEVICE WAS RECENTLY TESTED AND DIAGNOSTIC RESULTS SHOWED NORMAL DEVICE FUNCTION AND AN IFI CONDITION.

    Description of Event or Problem · 1

    THE PATIENT HAD A GENERATOR REPLACEMENT ON (B)(6) 2015 DUE TO BATTERY DEPLETION / END OF SERVICE. GENERATOR WAS RECEIVED FOR ANALYSIS ON 10/28/2015. PRODUCT ANALYSIS IS CURRENTLY UNDERWAY BUT HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595068 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 2530

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention