MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Complaint, Ill-Defined (2331); Neck Pain (2433)

Event Date 01/01/2015

Event Type  Injury  

Event Description

It was reported that the patient began feeling pain and a pulling type sensation in her neck.It was noted that there was no trauma.X-rays were taken and sent for review.Per the x-rays, the generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.The electrodes appear in proper alignment.Strain relief bend was present but not per labeling.No strain relief loop was present.Two tie-downs were observed but were not placed per labeling.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Part of the lead was behind the generator and could not be assessed.The presence of a micro-fracture in the lead cannot be ruled out.As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed.Based on the x-rays received, the cause for the pain and lead pulling sensation could possibly be due to the lack of proper strain relief.The patient was seen by the physician and the diagnostics (systems and normal mode) read normal.The doctor upped the output current to 1.0ma and reduced the pulse width to 250 to see if it would help with the side effects she was having.It was noted that the patient had been experiencing pain in her chest and a ¿pulling¿ sensation when the device is on.Since the doctor saw her last, she had a cluster of nocturnal seizures and now she is noticing more effect on her voice and pain when the device is on.She went to see an ent who investigated and was able to determine that her vocal cord was not moving when the device was on.The patient doesn¿t want to turn the device off, as she feels it is really helping with her seizures and she is able to ¿tolerate¿ the effects.The physician also mentioned the patient also has horners syndrome on the left side.

Event Description

The physician reported that the nocturnal seizures were unusual for the patient, however she has still experienced an overall decrease in her seizures compared to before vns.She also said that there was no way of telling if these seizures are related to vns or not and that they were not witnessed.

Event Description

On (b)(4) 2015, it was reported that the patient's painful stimulation is worsening (erratically, and more noticeable when active) as well as her voice hoarseness becoming worse and sometimes painful.This has been noticeable over the last 4-5 months.She also reports that since this time, she has noticed that several times, she has had a jolt from the stimulation and it feels like it takes her breath away.This most recently happened in (b)(6) 2015.The nurse mentioned that the diagnostics back in (b)(6) 2015 were within normal limits.

Event Description

An update was received on 06/24/2016 regarding the patient's voice issues.The patient was still experiencing voice issues, which were also occurring during off-times.The ent was concerned about possible vagus/laryngeal nerve damage because the issue is still occurring when the device was not stimulating.The patient's previous settings were decreased two separate times to alleviate the voice issues.The patient did not want to try a temporary disablement due to the possibility of an increase in seizures.The ent consult notes stated that the patient's laryngeal function was affected by vns, but the function and voice was improving.The notes did not explicitly mention laryngeal nerve damage.The patient's settings were recently adjusted to help with tolerability.The patient also reported having painful stimulation with magnet mode, but she has had fewer and milder seizures than pre-vns and is overall happy with vns therapy.No further relevant information has been received to date.

Event Description

The ent could not tell if the device was stimulating or not during his evaluation of the patient, so he could not comment on any dynamic changes in vocal cord function.The physician stated that the improvement in vocal cord function may have been due to the decrease in output current or because the device was not stimulating at the time of evaluation.The ent felt that it was reasonable to keep the patient's vns on and doubted that there would be any progressive decline in vocal cord function.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 4620110
• MDR Text Key: 15837428
• Report Number: 1644487-2015-04186
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2017
• Device Model Number: 302-20
• Device Lot Number: 202362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• 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: 50 YR