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

Model Number 303-20

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Dysphasia (2195); Choking (2464)

Event Date 04/13/2012

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that the patient experienced choking, increased blood pressure, increased heart rate and voice alteration with stimulation.Patient had gone to the er due to chest pain suspecting a heart issue but was told that the heart was fine.At the er it was found that patient's dilantin level was high and the er staff immediately tried to get her dilantin level down.Additional information was received that the patient's increased blood pressure and heart rate started since (b)(6) 2015.The neurologist referred patient to the surgeon to assess patient's chest pain, increased heart rate and blood pressure.The relationship of these events to vns therapy is unknown to the neurologist.Clinic notes were later received for the generator replacement, which noted that the patient experienced dysphagia, pain in the left upper extremity and burning around the site of vns, which does not radiate in to the neck.Patient's vns was also reported to have moved due to loss of weight.The surgeon did not recommend any changes due to the migration.Notes also indicated that the patient's vagus nerve was impaired with hoarseness.No known surgical interventions have occurred to date.

Event Description

The patient reported that she was scheduled to see the surgeon for consult.She indicated that she needs two procedures at the same time.The patient reported that the other procedure she requires is cardiac related for possible stent placement.The patient reported that she had an abnormal ekg, but it may be related to her vns.The patient underwent surgical consult and was referred to a cardiologist.No known surgical interventions have been performed to date.

Event Description

The physician's office reported that the patient will be undergoing a stress test and ekg and the physician is unsure of the relationship to vns at this time.No additional relevant information has been received to date.

Event Description

The patient underwent generator replacement.The explanted generator has not been received for analysis to date.The physician reported that the patient underwent cardiology consult and a stress test and there was no evidence of abnormality.The physician believes a 3d echo was performed.It was reported that the ekg was ok.

Event Description

The patient reported that she is still experiencing issues with her new generator.The patient reported that she is uncomfortable and it still hurts sometimes.The patient reported that she feels like it "jumps" around sometimes.The patient complained to the physician's office regarding erratic stimulation.The patient reported that vns isn't working.The patient reported that she is experiencing an increase in seizures and is concerned that something bad is going to happen to her.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

The physician reported that device diagnostics were within normal limits.The patient was encouraged to use the magnet more.The physician indicated that the device is working fine and that the seizures are at the patient's pre-vns baseline and that the patient feels she is still having seizures.

Event Description

A patient reported that she had experienced a weight loss of approximately 150 pounds since being implanted with her vns device in (b)(6) 2012.Follow-up with the patient's physician showed that the weight loss was related to vns and was due to experiencing left vocal cord paresis following the implant in (b)(6) 2012.Per the neurologist, the vocal cord paresis may have caused aspiration and thus diminished oral intake, resulting in weight loss.The family was reportedly well compensated as of (b)(6) 2016.The majority of the clinical symptoms reported are related to bodily structures near the lead site ( voice alteration, dysphagia, nerve damage, and vocal cord paresis ).Additionally, the reported events were not alleviated after generator replacement occurred on (b)(6) 2016.Diagnostics have reportedly been within normal limits with both generators.No additional relevant information has been received to date.

Event Description

The patient called and provided additional information that she had undergone surgery due to the previously reported vocal cord paralysis.Her surgery involved removing one of her vocal cords, reportedly.She stated that she was continuing to have an increase in seizures as previously reported.The patient's diagnostics with the new model 106 generator were all within normal limits.No further relevant information has been received to date.

Manufacturer Narrative

Date received by manufacturer, corrected data: supplemental mdr #7 inadvertently had the wrong date under.The date should have been 02/14/2017.

• 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: 5225867
• MDR Text Key: 31264707
• Report Number: 1644487-2015-06418
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2016
• Device Model Number: 303-20
• Device Lot Number: 201784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2012
• 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: 54 YR