• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK GENERATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 01/01/2012
Event Type  Injury  
Event Description

An article entitled ¿long-term results of vagal nerve stimulation for adults with medication-resistance epilepsy who have been on unchanged antiepileptic medication¿ was received. Forty-three patients were followed. After implant, patients were evaluated on a monthly basis increasing stimulation 0. 25 ma at each visit, up to 2. 5 ma. Medication was unchanged for at least 18 months since the stimulation was started. Of the 43 operated patients, 63% had a simulation or great than 50% reduction in seizure frequency. Differences in the responder rate according to stimulation intensity, age at onset of epilepsy, duration of epilepsy before surgery, previously epilepsy surgery, and seizure type, did not reach statistical significations. Most side effects were well tolerated. One patient reported an increase in the duration and intensity of his seizures. Twenty-two patients experienced side-effects. The most common were mild, consisting in hoarseness, neck tingling or occasional coughing at the time when the signal was on, all of which were usually well tolerated. Two patients had intermittent dyspnea, and another patient experienced occasional episodes of dysphagia with stimulation. Irritability was reported by two families, in the context of a general improvement in the level of alertness. Five had severe side effects, requiring their vns generators to be inactivated or explanted. Three of the 5 patients that stopped receiving stimulation had been responders. Reasons for explanation were infection in two patients, and odynophagia, in one patient. One patient had an exacerbation of a previous behavior disturbance, with severe aggressiveness, which improved when the stimulator was inactivated. Seizure reduction was maintained after the stimulation was stopped. Another stimulator was removed at family request, owing to a persistent abdominal pain. One explant due to infection is captured in this report: mfr report# 1644487-2013-01450. The other explant due to infection is captured in mfr report #1644487-2013-01453. The explant due to odynophagia is captured in mfr report #1644487-2013-01449. The explant due to abdominal pain is captured in mfr report #1644487-2013-01447. The report of increased seizure duration and intensity is captured in mfr report #1644487-2013-01444.

 
Manufacturer Narrative

Garci´a-navarrete e, et al. Long-term results of vagal nerve stimulation for adults with medication-resistant epilepsy who have been on unchanged antiepileptic medication. Seizure: eur j epilepsy (2012), http://dx. Doi. Org/10. 1016/ j. Seizure. 2012. 09. 008.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3120504
Report Number1644487-2013-01450
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/22/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/22/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/20/2013 Patient Sequence Number: 1
-
-