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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
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.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
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 Key6028201
Report Number1644487-2016-02352
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation PATIENT
Type of Report Followup,Followup
Report Date 07/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number303-20
Device LOT Number203560
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/23/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/21/2015
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: 10/13/2016 Patient Sequence Number: 1
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