MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL UNKNOWN

Model Number 302-30

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Pain (1994)

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.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5633094
• MDR Text Key: 44449488
• Report Number: 1644487-2016-00954
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,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 Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2005
• Device Model Number: 302-30
• Device Lot Number: 8664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR