BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2172590 · Received July 20, 2011

    Report

    Report Number
    1644487-2011-01619
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    July 30, 2007
    Report Date
    June 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011, A VNS TREATING PHYSICIAN REPORTED THAT THE VNS PATIENT WAS BEING SCHEDULED FOR BATTERY REPLACEMENT FOR PROPHYLACTIC REASONS BUT THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES, PRE-VNS BASELINE UNKNOWN. SINCE THEN, HOWEVER, THE GENERATOR HAS REACHED END OF SERVICE. ON (B)(6), 2011, THE VNS PATIENT WENT FOR BATTERY REPLACEMENT. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS THAT HAS NOT YET BEEN COMPLETED. CLINIC NOTES FROM THE PHYSICIAN WERE RECEIVED THROUGH CASE MANAGEMENT. REVIEW OF THE CLINIC NOTES DATED (B)(6), 2011 REVEALED THAT THE PATIENT WAS HAVING 1 SEIZURE EVERY 2-3 WEEKS AND THAT HER LAST SEIZURE WAS 2 WEEKS AGO. THE PATIENT WAS STATUS POST AN EXCISION OF ACOUSTIC NEUROMA AND HER SEIZURES BEGAN AFTER THIS SURGERY. THE PATIENT HAS A HISTORY OF ACOUSTIC NEUROMA RESECTION SINCE 1980, A PRE-VNS CONDITION. THE PATIENT'S HISTORY ALSO LISTS A STROKE; IT IS UNCLEAR AT THIS TIME ITS RELATIONSHIP TO VNS. CLINIC NOTES DATED (B)(6), 2011 REPORT THAT THE PATIENT CONTINUES TO HAVE SEIZURES AT ROUGHLY THE SAME FREQUENCY DESPITE THE INTRODUCTION OF VIMPAT. THE PATIENT FELT THAT SOMETHING WAS DIFFERENT OR NOT QUITE RIGHT SO HER VNS WAS CHECKED AND IT WAS DISCOVERED THAT THE VNS WAS AT ERI = YES. THE PATIENT WAS THEN REFERRED FOR BATTERY REPLACEMENT. CLINIC NOTES DATED (B)(6), 2010 STATE THAT THE PATIENT HAD MORE SEIZURES; OVER THE PAST TWO MONTHS SHE HAS HAD ABOUT 4 TO 5 COMPLEX PARTIAL SEIZURES WITH THE MOST RECENT OCCURRING THE DAY BEFORE. OTHERWISE, THE PATIENT HAS BEEN RELATIVELY FREE OF SEIZURES FOR THE PAST FEW MONTHS COMPARED TO HER TYPICAL FREQUENCY BEFORE THIS. IT WAS DISCUSSED THE POSSIBILITY OF INCREASING VIMPAT AND DECREASING CARBATROL TO SEE IF THAT WOULD HELP CONTROL HER SEIZURES BETTER. CLINIC NOTES DATED (B)(6), 2007 REPORTED THAT THE PATIENT HAD A SLIGHT INCREASE IN THE FREQUENCY AND DURATION OF SEIZURES WITH THE MOST RECENT INCREASE IN HER VNS OUTPUT TO 3.00MA. PREVIOUSLY SHE HAD SEIZURES EVERY 3 WEEKS, BUT AFTER THE CHANGE, SHE BEGAN TO HAVE SEIZURES EVERY TWO WEEKS. THE PATIENT ASKED TO HAVE THE DEVICE RETURNED TO THE PREVIOUS SETTING OF 2.75MA OUTPUT. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED NEGATIVE YEARS UNTIL ERI = YES. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE REPORTED END OF SERVICE ALLEGATION WAS DUPLICATED IN THE PRODUCT ANALYSIS LABORATORY AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY DEPLETION, BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE CASE MANAGER REPORTED THAT THE PATIENT'S BASELINE PRIOR TO VNS WAS 3-7 SEIZURES A MONTH BUT THE PATIENT VARIES WIDELY. THEREFORE, THE PATIENT'S INCREASES IN SEIZURES ARE BELOW OR AT THE SAME LEVEL AS PRE-VNS BASELINE FREQUENCY. THE CASE MANAGER ALSO SAID THAT THE PATIENT'S SODIUM LEVELS ARE NOT UNDER CONTROL DUE TO THE ANTIEPILEPTIC DRUGS AND THIS COMBINED WITH STRESS MAKE THE PATIENT HAVE MORE SEIZURES. SHE SAID THE PATIENT'S RECENT INCREASE IN SEIZURES AND THE CHANGE IN SEIZURE PATTERN IS DUE TO THE VNS BEING AT END OF SERVICE. THERE WAS A MEDICATION CHANGE ON (B)(6) 2010 WHERE THE PHYSICIAN STARTED HER ON VIMPAT. ON (B)(6) 2010 THE PHYSICIAN REPORTED THAT HE HAD ASKED HER TO DECREASE HER CARBATROL DOSE BY 300MG WHILE SHE INCREASES VIMPAT TO 150MG TWICE DAILY. THE CASE MANAGER REPORTED THAT THIS MEDICATION CHANGE IS LIKELY WHAT CAUSED THE PATIENT'S INCREASE IN SEIZURES AROUND THAT TIME PERIOD. THE CASE MANAGER THEN PROVIDED ADDITIONAL CLINIC NOTES FROM (B)(6) 2006 WHICH SHOWED THAT THE PATIENT HAD 10 SMALL SEIZURES AND ONE EVENT THAT WAS BIGGER THAN HER USUAL SMALL EPISODES IN EARLY (B)(6). THE PHYSICIAN REPORTED THAT THIS OCCURRED WHEN SHE WAS UNDER A SIGNIFICANT AMOUNT OF STRESS HOWEVER AND HAS BEEN HER TYPICAL PATTERN OVER THE PAST FEW YEARS. HE REPORTS THAT HE CAN'T SEEMINGLY GET ANY BETTER SEIZURE CONTROL FOR THE PATIENT DESPITE CHANGES IN MEDICATION AND THE VNS PARAMETERS. THE PHYSICIAN REPORTED THAT THE PATIENT'S STROKE THAT WAS LISTED IN THE CLINIC NOTES DATED (B)(6) 2011 IS A MISTAKE. THERE WAS NO STROKE AT ALL; THE PATIENT JUST HAD A CRANIAL NERVE INJURY STEMMING FROM A BRAIN SURGERY PERFORMED MANY YEARS AGO. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 015790

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention