BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 20427693 · Received October 11, 2024

    Report

    Report Number
    1644487-2024-01285
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    May 10, 2018
    Report Date
    October 11, 2024
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCES: 1. FALCO-WALTER J: EPILEPSY-DEFINITION, CLASSIFICATION, PATHOPHYSIOLOGY, AND EPIDEMIOLOGY . SEMIN NEUROL. 2020, 40:617-23. 10.1055/S-0040-1718719. 2. KWAN P, BRODIE MJ: EARLY IDENTIFICATION OF REFRACTORY EPILEPSY . N ENGL J MED. 2000, 342:314-9. 10.1056/NEJM200002033420503. 3. OGBONNAYA S, KALIAPERUMAL C: VAGAL NERVE STIMULATOR: EVOLVING TRENDS . J NAT SCI BIOL MED. 2013, 4:8-13. 10.4103/0976-9668.107254. 4. TOFFA DH, TOUMA L, EL MESKINE T, BOUTHILLIER A, NGUYEN DK: LEARNINGS FROM 30 YEARS OF REPORTED EFFICACY AND SAFETY OF VAGUS NERVE STIMULATION (VNS) FOR EPILEPSY. 5. BOON P, VONCK K, D'HAVE M, O'CONNOR S, VANDEKERCKHOVE T, DE REUCK J: COST-BENEFIT OF VAGUS NERVE STIMULATION FOR REFRACTORY EPILEPSY. ACTA NEUROL BELG. 1999, 99:275-80. 6. GONZÁLEZ HF, YENGO-KAHN A, ENGLOT DJ: VAGUS NERVE STIMULATION FOR THE TREATMENT OF EPILEPSY . NEUROSURG CLIN N AM. 2019, 30:219-30. 10.1016/J.NEC.2018.12.005 7. RANDALL WC, ARDELL JL, BECKER DM: DIFFERENTIAL RESPONSES ACCOMPANYING SEQUENTIAL STIMULATION AND ABLATION OF VAGAL BRANCHES TO DOG HEART. AM J PHYSIOL. 1985, 249:133-40. 10.1152/AJPHEART.1985.249.1.H133. 8. MCGREGOR A, WHELESS J, BAUMGARTNER J, BETTIS D: RIGHT-SIDED VAGUS NERVE STIMULATION AS A TREATMENT FOR REFRACTORY EPILEPSY IN HUMANS. EPILEPSIA. 2005, 46:91-6. 10.1111/J.0013-9580.2005.16404.X 9. SPUCK S, NOWAK G, RENNEBERG A, TRONNIER V, SPERNER J: RIGHT-SIDED VAGUS NERVE STIMULATION IN HUMANS: AN EFFECTIVE THERAPY?. EPILEPSY RES. 2008, 82:232-4. 10.1016/J.EPLEPSYRES.2008.08.003 10. NAVAS M, NAVARRETE EG, PASCUAL JM, ET AL.: TREATMENT OF REFRACTORY EPILEPSY IN ADULT PATIENTS WITH RIGHTSIDED. VAGUS NERVE STIMULATION. EPILEPSY RES. 2010, 90:1-7. 10.1016/J.EPLEPSYRES.2010.04.007 11. MCHUGH JC, SINGH HW, PHILLIPS J, MURPHY K, DOHERTY CP, DELANTY N: OUTCOME MEASUREMENT AFTER VAGAL. NERVE STIMULATION THERAPY: PROPOSAL OF A NEW CLASSIFICATION. EPILEPSIA. 2007, 48:375-8. 10.1111/J.1528- 1167.2006.00931.X. 12. KRAHL SE, SENANAYAKE SS, HANDFORTH A: RIGHT-SIDED VAGUS NERVE STIMULATION REDUCES GENERALIZED SEIZURE SEVERITY IN RATS AS EFFECTIVELY AS LEFT-SIDED. EPILEPSY RES. 2003, 56:1-4. 10.1016/S0920-1211(03)00122-0. 13. GIORDANO F, ZICCA A, BARBA C, GUERRINI R, GENITORI L: VAGUS NERVE STIMULATION: SURGICAL TECHNIQUE OF IMPLANTATION AND REVISION AND RELATED MORBIDITY. EPILEPSIA. 2017, 58:85-90. 10.1111/EPI.13678 14. GALBARRIATU L, POMPOSO I, AURRECOECHEA J, ET AL.: VAGUS NERVE STIMULATION THERAPY FOR TREATMENT-RESISTANT EPILEPSY: A 15-YEAR EXPERIENCE AT A SINGLE INSTITUTION. CLIN NEUROL NEUROSURG. 2015, 137:89-93. 10.1016/J.CLINEURO.2015.06.023. 15. KAHLOW H, OLIVECRONA M: COMPLICATIONS OF VAGAL NERVE STIMULATION FOR DRUG-RESISTANT EPILEPSY: A SINGLE CENTER LONGITUDINAL STUDY OF 143 PATIENTS. SEIZURE. 2013, 22:827-33. 10.1016/J.SEIZURE.2013.06.011 16. DEVINSKY O: EFFECTS OF SEIZURES ON AUTONOMIC AND CARDIOVASCULAR FUNCTION . EPILEPSY CURR. 2004, 4:43-6. 10.1111/J.1535-7597.2004.42001.X. 17. FAHOUM F, BOFFINI M, KANN L, FAINI S, GORDON C, TZADOK M, EL TAHRY R: VNS PARAMETERS FOR CLINICAL RESPONSE IN EPILEPSY. BRAIN STIMUL. 2022, 15:814-21. 10.1016/J.BRS.2022.05.016 18. HACHEM LD, WONG SM, IBRAHIM GM: THE VAGUS AFFERENT NETWORK: EMERGING ROLE. LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER RIGHT SIDED VNS IMPLANT, THE PATIENT HAD DEVELOPED PROLONGED CYANOSIS WITH FOCAL TO BILATERAL TONIC CLONIC [SEIZURES] (FBTCS) WHEN THE OUTPUT CURRENT WAS PROGRAMMED TO 1.5 MA. HIS SETTING WAS THEN DECREASED TO 1.375 MA AND THE CYANOSIS HAD RESOLVED. THE PATIENT STILL HAD 8-16 SEIZURES PER MONTH WITH R-VNS. HIS FBTCS ARE LESS FREQUENT AND INTENSE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326192 PULSE GEN MODEL 1000 GENERATOR LYJ CYBERONICS - HOUSTON 1000 204375 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other