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 Seizures (2063)

Event Date 09/01/2016

Event Type  Injury  

Event Description

It was reported that the patient cannot feel her magnet stimulation.The physician was concerned her battery may be nearing end of service.A battery life calculation was performed on 12/05/2016 and reviewed on 12/16/2016.The in-house programming history database contained information from 12/14/2014 through 06/25/2015.No anomalies were noted.Based on the information provided and available within the programming history database, the patient's device has approximately 5 years remaining until the neos = yes (near end of service) condition.It was later reported by the patient that she was concerned her device may not be working as she mentioned she used to always feel the stimulation and now she does not feel it at all.She also explained that her seizures have dangerously increased and the magnet stimulation does not have the same effect on her seizures as it used to.It was noted the increase in seizures first started in (b)(6), but in (b)(6) is when they became much more frequent and increased in duration.The patient explained the neurologist was able to interrogate her device, and during the visit he performed multiple magnet swipes which had been registered upon review of his programming system, indicating the magnet swipes were performed correctly.The patient stated the physician increased the vns settings and she still was unable to feel the device.She also explained that normally after a settings increase she would have a cough or irritation on the first day and would then become accustomed to the therapy, but this change in settings did not have the same effect.The in-house programming history database was reviewed and was found to contain information from 12/17/2014 through 06/25/2015.No anomalies were noted.The last diagnostics were performed on 06/25/2016 and showed the device was performing as intended and diagnostics were within normal limits.Clinic notes were later received in regards to a replacement referral for the patient's vns.It was found in the clinic notes that the patient had experienced 6 seizures since her last visit and that she still feels her vns is not working.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional clinic notes were received which showed that the patient's device was checked and programmed to new settings, showing the device could be communicated with at that point in time.It was also reported in those notes that the vns was less than 30%.In this set of clinic notes, the physician stated he would referred for vns generator replacement.Additional clinic notes were received which stated the physician had checked the device due to a reported increase in seizure frequency and intensity.The physician noted the vns was non-functioning and the patient was referred for replacement surgery.An implant card was received by the manufacturer showing the patient underwent generator replacement surgery on (b)(6) 2017.The explanted generator was received by the manufacturer.While analysis is expected, it has not been completed to date.

Event Description

Product analysis (pa) of the returned vns generator was completed.Pa successfully verified proper functionality of the generator and its ability to provide the appropriate programmed output currents.The generator was found to perform according to functional specifications and there were no performance, or any other types of adverse conditions, found with the vns generator.

• 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: 6236463
• MDR Text Key: 64271146
• Report Number: 1644487-2017-03004
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Model Number: 103
• Device Lot Number: 203044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: 2 YR
• Event Location: Other
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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): Required Intervention
• Patient Age: 34 YR