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

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problems Paralysis (1997); Dysphasia (2195)

Event Date 07/31/2014

Event Type  Injury  

Event Description

It was reported that the patient was experiencing voice alteration following a recent vns implant surgery.Patient's vns was not turned on during surgery on (b)(6) 2014 and the voice alteration was reported to be not related to stimulation.Information was later received that the patient's voice alteration had still not resolved after two months from vns implant.It is reported that the voice had improved but towards the end of the work week, patient's voice sounds like a whisper.Additional information was received that the patient was diagnosed with vocal cod paralysis in (b)(6) 2015.Patient is partially recovered but still has episodes of no voice form time to time.Patient believes it to be related to the surgery from which she never recovered fully.Patient's voice alteration was better but has returned recently.Voice alteration occurs with stimulation usually but also otherwise.Patient plays a saxophone in a band and she loses her voice for 24hr afterwards.Attempts for additional relevant information were unsuccessful.

Event Description

Additional information was received that the patient's left vocal cords were affected.No interventions were reported to have been taken and vocal cord issue was reported to have resolved spontaneously.The ent physician believed that the issue was caused by the vns surgery.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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 Key: 5124699
• MDR Text Key: 27440961
• Report Number: 1644487-2015-05999
• 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: company representative,consum
• Reporter Occupation: Patient
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Model Number: 304-20
• Device Lot Number: 202844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2014
• 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): Other
• Patient Age: 50 YR