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 Problems Muscle Spasm(s) (1966); Pain (1994); Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient was experiencing pain and muscle spasms in her neck and shoulder after her device settings were increased.The device settings were subsequently decreased and the pain resolved; however, the patient began experiencing an increase in seizures reported by the patient to be above pre-vns baseline levels.The patient¿s device was tested and diagnostic results showed normal device function.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Further follow up indicated that the patient¿s settings were lowered, and the neck and shoulder pain subsided.The vns was interrogated and results again showed normal device function.The patient then experienced an increase in seizures reportedly above the vns pre-therapy levels.An x-ray was reviewed by the patient¿s neurologist, and the leads appeared intact, it was unknown what the cause for the patient¿s pain.No additional relevant information has been received to date.

Manufacturer Narrative

Event Description

On (b)(6) 2015 it was stated that all non-vns issues were ruled out for the patient's pain.The patient continues to have pain when she turns her head to the left; however, she is unable to correlate the pain to stimulation.It was noted that the patient's increase in seizures were temporary and did not start with the pain.Further attempts have been made for additional information but have been unsuccessful to date.

Event Description

Follow-up with the physician's office showed that they do not feel that the vns device made the patient's seizures worse.External factors of stress and possible thyroid disease may have contributed to the seizures.Their records show the vns device to be operational.The patient was always able to perceived stimulation and it is only a painful sensation now.According to the physician, the etiology of the pain continues to be unclear.The feel it is unlikely related to vns.The emg is negative and patient was referred to pcp for evaluation of musculoskeletal pain.The nurse clarified what was mean by the "magnet was not working" by stating that they do not suspect any issues with the patient's magnet and have discussed magnet technique as well.She was not sure if the patient maybe could not feel the stimulation at times but the magnet and vns has worked for the patient and everything from their records shows that the device is functioning normally.

Event Description

On (b)(6) 2015, the patient reported that she is having an increase in seizures.The patient has been cleared of any cardiac or other medical causes for her symptoms.The nurse turned down the dosing at the most recent visit.The nurse wishes to keep decreasing the settings and perhaps even disable her device.However, the patient states she has always had excellent seizure control from vns and refuses disablement.Further follow-up with the patient's physician showed that the patient is very vague in her descriptions of her adverse events.The physician states it is unclear if the increase in seizures is related to vns therapy.The patient has had no obvious medication changes that would be contributing.The physician stated that it is hard to assess the seizures as it isn't always clear from her report if she had an actual epileptic seizure or just thinks that she did.Therefore baseline level is hard for him to assess.According to the physician, at this point, any surgical intervention would be based on patient request only.

Event Description

Patient underwent generator replacement on (b)(6) 2016 due to battery depletion.The explanted generator was received on 7/29/2016.Analysis is underway but has not been completed to date.

Event Description

Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation", "muscle spasm(s)", and "pain").In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The battery, 2.755 volts, shows an ifi=yes condition.There were no performance or any other type of adverse conditions found with the pulse 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: 4723849
• MDR Text Key: 5736837
• Report Number: 1644487-2015-04544
• 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: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2011
• Device Model Number: 103
• Device Lot Number: 2572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2010
• 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 Age: 34 YR