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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/01/2013

Event Type  Injury  

Event Description

Follow up with the physician found that the patient's pain was first observed in (b)(6) 2013 following the motor vehicle accident.The lack of efficacy was seen since vns implant in 2010.In response to the question about the relationship of the vns to the patient's pain, the physician said that the vns device was turned off on the initial visit on (b)(6) 2013.The pain was associated with stimulation and was occuring on the left side of the neck.The lack of efficacy from the vns was attributed to injury during motor vehicle accident, per the physician.The physician stated that the device was disabled by taping the magnet over it on the first visit.No other information was provided.

Event Description

It was reported that the patient's generator has been programmed off since (b)(6) and the patient now wants the device explanted.The neurologist indicated that the vns has never helped the patient and has caused her pain.It is unknown if the pain occurred with device stimulation.Attempts to obtain additional information have been unsuccessful to date.Surgery is likely, but has not occurred to date.

Event Description

Clinic notes dated (b)(6) 2014 were received stating that the patient had a vns device which was turned off one year earlier due to discomfort and without relief of seizures.The patient wanted the device removed.Follow up with the tc showed that the device was actually programmed off.Explant surgery has not occurred to date.Programming history in the in-house database was reviewed again on (b)(6) 2014 for updates.The last available settings are from (b)(6) 2013 showing that the device was programmed to: output current: 1.75 ma, frequency: 30 hz, pulsewidth: 500 usec, on time: 30 seconds, off time: 5 minutes, magnet output current: 2 ma, magnet pulsewidth: 500 usec, on time: 60 seconds.The device was programmed to these settings on (b)(6) 2012.

Event Description

The explanted generator and lead were reported to be available to return to the manufacturer.The products were received.However, analysis has not been completed to date.

Event Description

It was reported that the patient's physician kept trying to increase her vns programmed settings.As a result of settings programmed up too high in the patient's opinion, she reported having a "miserable" three months.After a severe accident which left her trauma icu care, she received a mri and the device went to "full force.".

Manufacturer Narrative

Date of event, corrected data: previously submitted mdr indicated an event date of (b)(6) 2013; however, additional information was received that the event date is (b)(6) 2013.This report is being submitted to correct this information.

Manufacturer Narrative

Analysis of programming history.

Manufacturer Narrative

Describe event or problem, evaluation codes, corrected data: the supplemental report #4 inadvertently reported this data incorrectly.The product was not discarded.

Event Description

Analysis was completed on the returned generator and lead.There were no performance or any other type of adverse conditions found with the pulse generator.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.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¿).In the analysis lab, the device output signal was monitored for more than 24-hrs, while the 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.Note that a portion of the lead assembly including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The incision and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted except for the setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time.What appeared to be canted spring indentations were observed on the rear end of the small o-ring.The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints.

Event Description

It was reported that the patient had generator and lead explant surgery on (b)(6) 2014.The operative notes reported that the patient was involved in a car crash trauma over two years ago."her seizures have resolved.Vagal nerve stimulator has been turned off for nearly 2 years.She has not had seizures and is desiring removal of her vagal nerve stimulator." the lead was dissected free from scar and fibrous tissue.The lead was divided from adherence to the jugular vein and carotid artery, "allowing the metallic portion to reside within the inflated outer portion in a position close to the muscle away from the vessels." the electrodes remained along the vagus nerve.The remaining generator and portion of the lead were removed.It was reported that the explanted devices are believed to have been discarded.The hospital representative reported that he did not receive the devices after the procedure to return to the manufacturer.Therefore, analysis cannot be performed.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3559261
• MDR Text Key: 4168379
• Report Number: 1644487-2014-00105
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2013
• Device Model Number: 103
• Device Lot Number: 201717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2011
• 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; Required Intervention
• Patient Age: 59 YR