BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2853208 · Received November 30, 2012

    Report

    Report Number
    1644487-2012-03164
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    August 15, 2012
    Report Date
    November 2, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH CLINIC NOTES, RECEIVED ON (B)(6) 2012 AND DATED (B)(6) 2012, THAT THE PATIENT HAD BEEN HAVING DAILY MORNING SEIZURES DURING THE FIRST WEEK OF SCHOOL, WHICH HAD SINCE DECREASED IN FREQUENCY TO THE PATIENT'S BASELINE OF 1-2 PER MONTH. IT IS UNCLEAR AT THIS TIME IF THIS INCREASE IN SEIZURES IS RELATED TO VNS AS PER THE PATIENT'S MOTHER, THEY MAY BE RELATED TO STRESS, LACK OF SLEEP AND ILLNESS. THE PATIENT HAS SINCE BEEN REFERRED FOR REVISION DUE TO BATTERY DEPLETION. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT A GENERATOR REVISION ON (B)(6) 2012. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE AS PER THE HOSPITAL; THEY ARE UNSURE OF IT'S LOCATION AND DO NOT HAVE IT TO RETURN. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE TREATING NEUROLOGIST HAVE ALSO BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. AN END-OF-SERVICE WARNING MESSAGE FROM THE GENERATOR 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. A RESET OF THE PULSE DISABLE BIT IN THE GENERATOR MEMORY WAS PERFORMED TO ALLOW FOR AN OUTPUT TO ONCE AGAIN BE PROVIDED BY THE GENERATOR FOR SUBSEQUENT TESTING. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE BATTERY, 2.075 VOLTS AS MEASURED DURING COMPLETION OF TEST PARAMETER OF THE FINAL ELECTRICAL TEST, SHOWS AN NEAR END OF SERVICE CONDITION. THE POST BURN-IN ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE DATA IN THE DIAGACCUM CONSUMED MEMORY LOCATIONS REVEALED THAT 105.674% OF THE BATTERY HAD BEEN CONSUMED. OTHER THAN THE NOTED CONDITION, THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2617

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention