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

Model Number 304-20

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 03/28/2017

Event Type  Injury  

Event Description

It was reported that a patient was experiencing pain in the neck area.The patient's device was disabled in response to the pain, but the pain continued.The physician performed x-rays and found no abnormalities, and diagnostics were within the normal limits.The physician mentioned that the patient recently had a soft tissue infection in the same area she was experiencing the pain, and he believed the pain was being caused by the infection.The physician did not believe the infection was related to the vns device.It was later reported that the patient went to the er as she continued to experience pain in her neck.An ultrasound revealed that the patient did have a soft tissue mass under her vns.The patient was referred to neurosurgery.No additional relevant information has been received to date.No surgical intervention has been taken to date.

Event Description

A nurse reported that the patient was seen recently at the office, and no surgical intervention had been taken for the patient's pain.More imaging was performed, but a mass was not visualized in the recent images.The treating medical assistant reported that the soft tissue mass was not infected.The physician could not identify a cause of the mass.No additional relevant information has been received to date.No surgical intervention has been taken to date.

Manufacturer Narrative

Describe event or problem, corrected data: supplemental report #01 inadvertently did not include information regarding the status of the device.

Event Description

The patient's device had been programmed on at a subsequent clinic visit, as the neck pain was not occurring with stimulation.No additional relevant information has been received to date.No surgical intervention has occurred to date.

• 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: 6513471
• MDR Text Key: 73447979
• Report Number: 1644487-2017-03656
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: 304-20
• Device Lot Number: 203077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• 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: 36 YR