MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphasia (2195); Injury (2348); Sore Throat (2396)

Event Date 04/15/2016

Event Type  Injury  

Event Description

It was reported by the physician that he wanted to start the process of getting the patient's explant scheduled as the patient had been having issues for the previous 6 months.The patient's "issues" were later explained as having a tickling sensation in her throat, voice alteration, she thought that the lead had moved in her throat and was touching her vocal cords.The patient stated these events happened about 6 months prior to the initial report and that it occurred after she was choked by her boyfriend.It was noted that x-rays were taken and reviewed and the vns had not moved.The vns was checked and the device was working as intended as the diagnostics were within normal limits.The patient was scheduled for surgery.The patient later stated that she didn't want the vns explanted as it did help her; however, if something could be done for the lead issue, as in a lead revision or exploratory surgery, she would be up for doing that.The surgeon's office tried to call the patient to see if she still wanted to be scheduled for surgery, but the patient was not answering.Therefore, the surgeon's office stated they would leave her on the surgery schedule until they hear back.Attempts for additional relevant information have been unsuccessful to date.No known surgical interventions have occurred to date.

Event Description

It was noted the patient stated her voice had been raspy since the assault and that she believed the vns lead is touching her vocal cords.She also explained she thinks the lead wires have moved and she can feel them now touching her vocal cords and protruding in her neck which did not occur prior to the assault.Additionally, the patient stated that she notices the magnet does not stop her seizures any more like they did before the assault.The nurse practitioner followed up with the patient and it was noted there were no more issues or complaints with the vns.The vns lead issue the patient was having resolved and no more follow-up is needed.It was explained by the nurse practitioner that the patient is a bit dramatic and decided she does not want to have the vns revision at this time.

• Brand Name: LEAD MODEL 303
• 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: 6086942
• MDR Text Key: 59451743
• Report Number: 1644487-2016-02594
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

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: 07/31/2013
• Device Model Number: 303-20
• Device Lot Number: 201156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2009
• 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: 30 YR