MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported by the patient that she was having pain in her neck area.The pain was later described as a sharp-jabbing pain in her neck and feels as if the "lead is broken in half and the wires are poking" into her neck.It was noted by the physician that the patient does have a history of hypersensitivity.The programming history database was reviewed and it showed that the patient's generator was functioning as intended on (b)(6) 2016 and the impedance values was within normal limits.The patient was seen by the physician on (b)(6) 2016 and it was noted the impedance was still within normal limits and working correctly.X-ray images were reviewed by the manufacturer and it was found that the vns tie-downs, which hold the lead in place, appeared superficial in the neck.No cause for the patient's pain could conclusively be determined by the company representative that reviewed the x-rays; however, the patient's surgeon was interested in reviewing the images.The patient had been referred to a surgeon for possible replacement due to the reported pain.No known surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported the patient had been seen by the neurosurgeon for an assessment as he was trying to determine the best step to take for the patient.It was noted the diagnostics continued to come back as normal and the patient feels like she needs to be turned back on as she was getting seizure control when the device was programmed on.However, it was noted when the device was turned on, the patient was having voice discomfort, but she also had a hoarse voice when the device was programmed off.Additional information was received stating the patient is returning to rhode island and her previous surgeon will be explanting the device as she does not want it anymore.It is unknown if the device is being explanted due to the reported poking feeling, due to the reported voice issues, or both.The reports of vocal cord paralysis and associated symptoms have been captured in mfr.Report 1644487-2016-02397.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported by the surgeon that he had explanted the patient's vns generator and lead due to a presumed malfunction.The exact date of the explant was not provided.Attempts for additional relevant information from the surgeon have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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: 6096833
• MDR Text Key: 59775204
• Report Number: 1644487-2016-02622
• 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 Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2016
• Device Model Number: 103
• Device Lot Number: 3886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2014
• 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): Required Intervention