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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
Event Date 01/01/2014
Event Type  Injury  
Event Description

It was reported that the patient indicated that he was to undergo neck surgery due to laryngeal nerve damage from vns. It was reported that the patient was experiencing laryngeal spasms post vns implant. The surgeon indicated that the patient experienced "unusual vocal spasms during device stimulation"; however, no specific details were provided. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

Additional information was received stating that the vns patient was referred for surgical consult due to dysphonia. The patient experienced a significant deterioration in voice quality following vns implant on (b)(6) 2011. Upon examination using a flexible fiberoptic, it was noted that the patient had periodic hyper-adduction of the left vocal cord. The left arytenoid excessively rotated medially preventing the right vocal fold from closing appropriately which caused the deterioration in voice quality. During stimulation off times, the vocal fold would return to midline position but did not move normally. When the device was disabled using the magnet, the phenomenon would stop. The surgeon stated that the event was due to vns stimulation. Laryngeal adductor botox administration improved the patient¿s symptoms but did not eliminate them. The patient was taken to the or to cut the recurrent laryngeal nerve by performing an ansa to rln reinnervation.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key3887010
Report Number1644487-2014-01557
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/23/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2015
Device MODEL Number304-20
Device LOT Number201874
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/24/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/14/2011
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: 06/20/2014 Patient Sequence Number: 1
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