BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2901881 · Received January 8, 2013

    Report

    Report Number
    1644487-2013-00048
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    October 5, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 CLINIC NOTES DATED (B)(6) 2012 WERE RECEIVED IN REFERENCE TO A VNS PATIENT. REVIEW OF THE CLINIC NOTES REVEALED THAT THE PATIENT CONTINUES TO HAVE BREAKTHROUGH SEIZURES WITH ALTERED AWARENESS AND SOME BLURRY VISION BUT NO CONVULSIVE ACTIVITY. THE BREAKTHROUGH SEIZURES WERE ORIGINALLY REPORTED ON (B)(6) 2012 WHICH WAS THE PATIENT'S LAST OFFICE VISIT PRIOR TO (B)(6) 2012. THE PATIENT WAS SWITCHED FROM DEPAKOTE TO TOPIRAMATE DUE TO WEIGHT GAIN WHILE TAKING DEPAKOTE. THE MEDICATION CHANGE WAS SAID TO HAVE MIXED RESULTS WITH THE SEIZURES BEING MORE FREQUENT LASTING 10 TO 20 SECONDS. THE PATIENT WAS ALSO HAVING SOME DIFFICULTY FINDING WORDS HOWEVER THE PATIENT HAS NOT GAINED WEIGHT AND WAS SAID TO BE FEELING BETTER ON THE TOPIRAMATE. DURING THE PATIENT'S LAST VISIT ON (B)(6) 2012 THE IFI (INTENSIFIED FOLLOW UP INDICATOR) WAS OBSERVED WHEN THE VNS DEVICE WAS CHECKED AND THE PATIENT WANTED TO HAVE THE DEVICE CHECKED TO SEE IF THE BATTERY STATUS OF THE GENERATOR HAD ANYTHING TO DO WITH THE SEIZURES. WHEN THE DEVICE WAS CHECKED ON (B)(6) 2012 THE IFI WAS STILL SHOWING YES AND THE BATTERY CAPACITY REMAINING WAS APPROXIMATELY 25% WHICH IS THE SAME AS IT WAS WHEN THE VNS DEVICE WAS CHECKED ON (B)(6) 2012. THE PHYSICIAN FELT THAT THE SEIZURES THE PATIENT WAS EXPERIENCING WAS EITHER DUE TO THE MEDICATION CHANGE (DEPAKOTE TO TOPIRAMATE) OR DUE TO THE VNS DEVICE BATTERY BEING CLOSED TO END OF SERVICE. THE PHYSICIAN WANTED TO HAVE THE VNS DEVICE REPLACED AS IT HAD WORKED VERY WELL FOR THE PATIENT IN TERMS OF SEIZURE CONTROL. THE PATIENT HAS BEEN REFERRED FOR GENERATOR REPLACEMENT SURGERY HOWEVER SURGERY HAS NOT OCCURRED TO DATE. THE PATIENT'S PROGRAMMING HISTORY AVAILABLE IN THE MANUFACTURER'S IN-HOUSE DATABASE WAS REVIEWED AND ON (B)(6) 2012, THE BATTERY STATUS READ 'OK' INDICATING THAT IT WAS NOT AT END OF SERVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    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.

    Description of Event or Problem · 1

    THE PHYSICIAN RESPONDED TO ATTEMPTS FOR MORE INFORMATION BUT DID NOT ADDRESS THE QUESTIONS RELATED TO THE INCREASE IN SEIZURES. THE PATIENT HAD A GENERATOR REPLACEMENT. GOOD FAITH ATTEMPT FOR THE GENERATOR RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. 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. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 2.724 VOLTS AS MEASURED DURING COMPLETION OF TEST PARAMETER OF THE FINAL ELECTRICAL TEST, SHOWS AN IFI CONDITION. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 77.799% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9873 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2586

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other