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


  • 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

Model Number 302-30
Event Type  Injury  
Event Description

It was reported the patient will have a vns generator replacement due to end of service, but the patient's mother would also like the lead replaced because she thinks the lead was compromised and is causing the patient jaw pain, head pain, and lower back pain. However, clinic notes from the physician were received and it was noted the patient has trigeminal neuralgia. The painful events are described as daily episodes lasting for hours. The pain starts in the patient's left lower jaw, where previously a tooth had been pulled, followed by midline low back pain, and frontal headache. The patient was seen in the epilepsy monitoring unit in 2013 and it was found that these events were not seizures. It was noted the patient does have trigeminal neuralgia, but replacing the lead will ensure the vns is not causing the pain. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Information was incorrectly reported on the initial mfr. Report.

Event Description

It was reported by the physician's office the patient's surgery will be for patient comfort. It was also noted the patient did not sustain any injuries from vns and trigeminal neuralgia is believed to be the cause of the patient's pain.

Event Description

It was reported the patient underwent generator replacement surgery on (b)(6) 2016. The explanted generator was confirmed to be neos = no. The lead impedance with the new generator was noted to be ok at 1408 ohms, which is within normal limits. It was noted that the surgeon only replaced the generator. It was later reported by the mother that the patient's vns was implanted for 12 years and it worked great. In 2011, the patient had a tooth on the left side that rotted and was removed. Two weeks after the tooth removal, the patient began having "episodes" of pain which began to occur daily. The patient was placed in the emu (epilepsy monitoring unit) and it was found these "episodes" were not seizures. The mother reported the physician thinks it is related to nerve damage. After the generator replacement on (b)(6) 2016 the patient reportedly had an "episode" which lasted 5 hours on (b)(6) 2016, and another which lasted 8 hours the next day. The mother believes the episodes are caused by vns and she wants her daughter to have a lead revision. It was noted the surgeon does not want to replace the leads without evidence there is a problem with the lead, since the diagnostics are currently ok. The mother stated she wants the patient's neck site opened to see if there could be anything affecting the lead. It was noted that a ct scan was performed, but it did not show any abnormalities. It was reported that the mother had also called the patient's physician and noted the patient is having severe jaw pain and has been seen in the er. Product analysis for the explanted generator was completed. The generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the generator.

Event Description

It was later reported that the patient used her magnet to turn off the device and the pain would go away. It was noted by the patient's mother that the settings were lowered from before and the patient's pain did subside. It was then that is was explained to the patient that the magnet could also be used to disable the device.

Event Description

It was reported by the patient's physician that the patient had transferred to a new neurologist. The new neurologist was contacted about the patient's issues and it was noted that the patient would not be referred for an additional surgery. It was also stated the pain is not related to vns and could be trigeminal neuralgia. The patient's vns was programmed off.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key5633094
Report Number1644487-2016-00954
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup,Followup,Followup,Followup
Report Date 04/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2005
Device MODEL Number302-30
Device LOT Number8664
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/01/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/25/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 05/04/2016 Patient Sequence Number: 1