MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

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

Patient Problems Dehydration (1807); Fever (1858); Undesired Nerve Stimulation (1980); Pain (1994); Paralysis (1997); Pneumonia (2011); Swelling (2091); Dysphasia (2195); Sore Throat (2396); Choking (2464)

Event Date 09/12/2016

Event Type  Injury  

Event Description

It was reported on 09/20/2016 that the patient is experiencing a sore throat and has been choking on his food.Other side effects since his implantation surgery include his voice altering.When he drinks he feels like it is going down his left lung.On 09/14/2016 he stated he got a fever of 103.9.He went to hospital, and found he had aspiration pneumonia and was dehydrated.No fever now.Was taught how to swallow to prevent aspiration but still doesn't help him.He states voice is still scratchy and vibrating.No redness or heat.Full neck swelling is better but incision swallow and lump is still there.He feels like someone is squeezing his esophagus.When trying to speak, he has to push really hard and use a lot of effort to get sound out.He feels like the lead is super tight.It was reported on 10/04/2016 that the patient cannot talk due to his vns surgery.He said his voice is slightly better, best in morning and gets worse throughout the day.Has to push air very hard to get sounds out.He states that he feels that the wire is too tight.If turns head to right and can feel it pulling.Had swallow study - any liquid gets stuck in back of throat and has hard time getting down to stomach.He states sometimes it goes down in lungs and coughs it out.Immediately post op he says he was dehydrated because he couldn't swallow.And he had aspiration pneumonia.He did state a x-ray was done by neurosurgeon who told him it was placed correctly.Patient thinks the surgery damaged one of the nerves coming off the vagus nerve.That he cut too far toward the front of the neck and nicked a nerve.Ent said that he has left vocal cord paralyzed and could take 6mo to 3 years to recover, but may not improve.He also recommended that vns be taken out.The vns is currently not programmed on.No known surgical intervention has occurred to date.

Event Description

The patient's surgeon has not seen them since surgery therefore no further information is known about the adverse events.No additional relevant information has been obtained to date.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had a few problems since implant.The patient reported that his leads were hurting and causing a shocking pain in the neck area.As a result of the shocking pain, he experienced headaches.He also described a soreness in the neck area that he believed to be due to the shocking vns stimulation and the lead wire being too tight.No further relevant information has been received to date.No known relevant intervention has occurred to date.

• Brand Name: LEAD MODEL 303
• 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: 6028201
• MDR Text Key: 57400539
• Report Number: 1644487-2016-02352
• 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: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2019
• Device Model Number: 303-20
• Device Lot Number: 203560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/23/2017
• Supplement Dates FDA Received: 11/17/2016; 12/16/2016; 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• 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): Other
• Patient Age: 48 YR