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

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Nerve Damage (1979); Complaint, Ill-Defined (2331)

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.

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.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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 Key: 3887010
• MDR Text Key: 17571576
• Report Number: 1644487-2014-01557
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• 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 Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 304-20
• Device Lot Number: 201874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR