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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/10/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that this patient is experiencing vocal cord paralysis. The surgeon believes it might be due to the vns strangulating the nerve. Therefore a vns lead revision occurred to determine if nerve strangulation is the cause. It was later reported that the patient began having sharp pains up her left ear to her left suboccipital area when her output current was increased. The patient had numbness of her left neck, left throat and left tongue. This made swallowing difficult. This did not get better with time, and when the output current was turned back down, she did not feel any stimulation unless her head was tilted to the left. It was mentioned that the doctor reported that the patient's nerve was pretty sizeable. The sharp pain that led to the patient's ear and suboccipital area was occurring with stimulation. It was also reported that it was too early to know the cause of painful stimulation, numbness, and vocal cord paralysis. The doctor spent 8 hours in the operating room probing the patient to determine what to do, and decided to cut the anchor tether, and snipped off the end of the positive electrode, and per the doctor, he did not cut any wire. He also believed the negative electrode was kinked and he fixed that. Overall the doctor kept the implanted lead intact with some modifications. The patient's generator was programmed off to allow the nerve to rest after surgery. No additional relevant information has been received to date.

 
Manufacturer Narrative

Date of event, corrected data: initial report inadvertently listed wrong date of event.

 
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Brand NameLEAD MODEL 304
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 Key6878406
Report Number1644487-2017-04480
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number5064
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/25/2016
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: 09/20/2017 Patient Sequence Number: 1
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