BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2871550 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03323
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 13, 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

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PHYSICIAN REPORTED THAT THE PATIENT¿S SEIZURES HAVE IMPROVED SINCE THE GENERATOR REPLACEMENT SURGERY IN (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(4) 2012 THAT THE PATIENT HAD A GENERATOR REPLACEMENT ON (B)(6) 2012. ON (B)(6) 2013, IT WAS INDICATED BY THE TREATING THE PHYSICIAN THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURE OVER THE LAST MONTH. THE INCREASE IN SEIZURES WAS BELOW PRE-VNS BASELINE LEVELS. THE PHYSICIAN BELIEVES THAT THE INCREASE IN SEIZURES IS DUE TO LOSS OF THERAPY AND STATES THAT THE BATTERY REVISION WAS TAKEN AS AN INTERVENTION FOR THE PATIENT'S INCREASED SEIZURES. THE SEIZURES ARE SAID TO BE AT OR BELOW BASELINE LEVELS CURRENTLY. THE PATIENT HAS DROP ATTACKS AND THERE WERE NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS THAT PRECEDED THE ONSET OF THE SEIZURES. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 WERE RECEIVED FOR THE PATIENT'S UPCOMING GENERATOR REPLACEMENT SURGERY. THE NOTES INDICATED THAT THE PATIENT RECENTLY HAD AN INCREASE IN DROPS AND FALLS WITH SELF-INJURIOUS BEHAVIOR AND RESULTS. IT WAS INDICATED THAT THE PATIENT'S GENERATOR WAS AT 18% BATTERY REMAINING. THE PATIENT WAS SCHEDULED FOR REVISION. IT IS UNCLEAR AT THIS TIME IF REVISION HAS OCCURRED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS FOR THE GENERATOR WAS COMPLETED. 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 SHOWS A NEAR END OF SERVICE (NEOS) CONDITION. A REVIEW OF THE INTERNAL MEMORY LOCATIONS WITHIN THE GENERATOR SUGGESTS THE EXISTENCE OF AN ERROR IN CALCULATING THE DEVICE'S TOTAL CONSUMED ENERGY RESULTING IN INCORRECT DEVICE LONGEVITY ESTIMATE. OTHER THAN THE NOTED CONDITIONS, THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    THE PATIENT'S EXPLANTED GENERATOR WAS RETURNED FOR ANALYSIS AND IS PENDING COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201020

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention