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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2015
Event Type  Injury  
Event Description

It was reported on (b)(6) 2015 that the patient has reported left vocal cord dysfunction. The onset of the event is unknown. The patient has consulted with an ent surgeon on whether or not any intervention needs to be taken.

Event Description

It was reported that the patient saw a local ent and the neurologists have yet to see the patient in the office. She was not complaining at all when they previously saw her. Further follow-up showed that the patient has been wheezing, having shortness of breath, and difficulty walking short distances. She thought her asthma was flaring up so she saw her primary physician. He noticed that the wheezing was coming from her throat. She was sent to ent and had further testing done. She was told she has vocal cord dysfunction most likely from the vns.

Event Description

(b)(6) 2016 notes state that the patient is here to have the vns settings decreased. Since having her duty cycle increased in august, she has been experiencing problems related to her vns. She has been wheezing, has shortness of breath, and cannot tolerate walking short distances or going up a flight of stairs. She saw an ent and was told she has vocal cord dysfunction. The md decreased duty cycle from 35% to 29%. (b)(6) 2016 -patient left to do stairs and walk briskly; came back and is still having problems with wheezing and shortness of breath. Turned device off and repeated, wheezing and shortness of breath gone totally. She feels much better. But with device off feels like she is having muscle spasms near vagus nerve, could feel the quiver of left neck which also affected her speech. Device was then decreased to 0. 5 ma then back to 1. 5 ma. So patient was set back to 1. 5 ma and will be seen in a few weeks to reduce if necessary. (b)(6) 2016 notes state the home pulmonary and ent specialists state that the wheezing while exercising is related to vns. When the vns was stopped she was able to exercise quite well without difficulties. They state that may indicate significant airway obstruction related to vagus nerve stimulation. Notes state they will get her down to 1 ma and cycle 30 sec on and 5 min off and see if that becomes more manageable in terms of her breathing.

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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key5341090
Report Number1644487-2016-00024
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Type of Report Initial,Followup,Followup
Report Date 12/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/04/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2008
Device MODEL Number302-20
Device LOT Number1090
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/12/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 01/04/2016 Patient Sequence Number: 1