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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

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CYBERONICS - HOUSTON LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/02/2016
Event Type  Injury  
Event Description

It was reported that the patient¿s left vagus nerve was damaged. The patient¿s treating ent physician stated that it appeared to occur during a surgery, but it was not clear if vns surgery or a prior brain surgery was responsible. It was believed the site of the damage was slightly higher than the level of the vns leads, specifically referencing damage at the palate region of the nerve. The ent physician reportedly performed a laryngoscopy and showed the patient had reduced sensation of the larynx, and muscle activations were delayed and less forceful. A modified variance swallow study was performed, and the tongue muscles and general pharyngeal muscles were found to not perform as well as they should. The physician¿s assessment of the issue was that since the left vagus nerve innervates the left palate, and the patient¿s left pallet did not elevate, the results signified damage to that vagus nerve. However, patient¿s vocal cords were reported to be normal. Knowing that left palate is innervated higher up on the vagus nerve, the damage was assessed by the physician to possibly have happened prior to vns. The patient was confirmed to have multiple other brain surgeries, including brain tumor removal, over the course of his life. However, the patient's vns surgery could not be ruled out as a contributing factor.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6252761
Report Number1644487-2017-03030
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 01/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/15/2018
Device MODEL Number303-20
Device LOT Number4039
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/20/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/22/2014
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: 01/14/2017 Patient Sequence Number: 1
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