PULSE GEN MODEL UNK
Report
- Report Number
- 1644487-2013-01495
- Event Type
- Injury
- Date Received
- May 21, 2013
- Date of Event
- January 1, 2012
- Report Date
- April 29, 2013
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
RYZI M, BRAZDIL M, NOVAK Z, CHRASTINA J, OSLEJSKOVA H, REKTOR I, ET AL. LONG-TERM VAGUS NERVE STIMULATION IN CHILDREN WITH FOCAL EPILEPSY. ACTA NEUROL SCAND. 2012. HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/22994298.
AN ARTICLE ENTITLED ¿LONG-TERM VAGUS NERVE STIMULATION IN CHILDREN WITH FOCAL EPILEPSY¿ WAS RECEIVED. THE ARTICLE REVIEWED ONE AND TWO YEAR EFFICACIES OF 15 PATIENTS IMPLANTED WITH A THERAPY SYSTEM. OF THE 15 PATIENTS, 7 WERE RESPONDERS AT ONE YEAR AFTER IMPLANT, NINE WERE RESPONDERS AT TWO YEARS AFTER IMPLANT, AND NINE WERE RESPONDERS AT FIVE YEARS AFTER IMPLANT. INITIAL SETTINGS WERE PROVIDED. THE OUTPUT CURRENT WAS INCREASED IN TWO WEEK INCREMENTS OF 0.25 MA TO A TARGET INTENSITY OF 01.50 MA TO 2.0 MA DEPENDING ON EFFICACY AND THE PRESENCE OF SIDE EFFECTS. RAPID CYCLES (ON TIME: 3.0 SECONDS, OFF TIME: 1.8 MINUTES AND ON TIME: 7 SECONDS, OFF TIME: 18 SECONDS) WAS USED IN ALL PATIENTS WHO WERE CLASSIFIED AS NON-RESPONDER AT ONE YEAR. MEDICATIONS WERE KEPT UNCHANGED DURING THE FIRST SIX MONTHS. THE ARTICLE CONCLUDED THAT VAGUS NERVE STIMULATION IS AN EFFECTIVE METHOD OF TREATING CHILDREN WITH REFRACTORY FOCAL EPILEPSY. IT LED TO A SUBSTANTIAL DECREASE IN THE NUMBER AND DURATION OF URGENT HOSPITALIZATIONS. THE ARTICLE INDICATED THAT ONE PATIENT EXPERIENCED SEVERE ADVERSE EFFECTS REQUIRING EXPLANT OF THE DEVICE. THE PATIENT EXPERIENCED REPETITIVE ATTACKS OF CARDIAC ASYSTOLIA, SOMETIMES ASSOCIATED WITH SYNCOPE AT THE TIME WHEN THE DEVICE WAS SWITCHED ON. THE SYNCOPES STARTED AFTER MORE THAN ONE YEAR OF STIMULATION. THE ASYSTOLE WAS STRICTLY RELATED TO THE ON STATUS OF THE DEVICE AND WAS NOT RELATED TO PATIENT SEIZURES.¿ THIS WAS PROVIDED BY VIDEO-EEG MONITORING. THE PATIENT DID NOT RESPONSE TO VNS; THEREFORE, THE OUTPUT CURRENT WAS NOT ADJUSTED. THE DISCONTINUATION OF VNS LED TO THE COMPLETE CESSATION OF THESE SYMPTOMS. THE CARDIOLOGICAL INVESTIGATIONS PERFORMED ON THIS PATIENT BOTH PRE-OPERATIVELY AND POST-OPERATIVELY (DURING THE OFF TIMES) REVEALED NO ABNORMALITIES. OTHER SEVERE ADVERSE EFFECTS WERE NOT OBSERVED. THE EXPLANT DUE TO CARDIAC EVENTS IS CAPTURED IN MFR REPORT #1644487-2013-01439. URGENT HOSPITALIZATIONS WERE ALSO REPORTED FOR NINE PATIENTS IN THE POST-OPERATIVE PERIOD. THIS WAS DEFINED AS HOSPITALIZATION BECAUSE OF AN INCREASE IN SEIZURE FREQUENCY WITH A CHANGE OR ADJUSTMENT IN THE LONG-TERM AED TREATMENT OR BECAUSE OF AN ADVERSE EVENT, A COMPLICATION OF THE EPILEPSY ITSELF, OR AN AED TREATMENT THAT LEAD TO ANY PERMANENT THERAPEUTIC TREATMENTS. THIS REPORT CAPTURES THE URGENT HOSPITALIZATION FOR AN INCREASE IN SEIZURE FREQUENCY FOR PATIENT 5 OF 9. ADDITIONAL REPORTS ARE CAPTURED IN MFR REPORT #1644487-2013-01490, MFR REPORT #1644487-2013-01491, MFR REPORT #1644487-2013-01493, MFR REPORT # 1644487-2013-01494, MFR REPORT #1644487-2013-01496, MFR REPORT #1644487-2013-01497, MFR REPORT #1644487-2013-01498, MFR REPORT #1644487-2013-01499 THE ARTICLE ALSO NOTED THAT COUGH, HOARSENESS, AND MILD DYSPHAGIA WERE OBSERVED IN 12 OF THE 15 PATIENTS REVIEWED. IN NONE OF THESE PATIENT¿S WAS THE SEVERE EFFECT A REASON FOR DISCONTINUATION OF VNS, AND THE EFFECT RESOLVED COMPLETED BY THE NEXT VISIT.
ADDITIONAL INFORMATION WAS RECEIVED THAT ALL OF THE REPORTED ADVERSE EVENTS (EXCEPT FOR THE CARDIAC EVENT) WERE MILD, TEMPORARY, AND OVERALL IN LINE WITH THE EXPERIENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224410 | PULSE GEN MODEL UNK | GENERATOR | LYJ | CYBERONICS, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |