MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problems Chest Pain (1776); Undesired Nerve Stimulation (1980); Neck Pain (2433)

Event Date 12/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Report received that a patient experienced sharp pain in her neck with stimulation that started after she walked through security scanners at departments stores.The patient also reported feeling continuous stimulation for awhile after walking through these scanners.The patient did not feel as if her magnet stopped the feeling of stimulation.The patient was admitted to the er where diagnostics were taken.The results were within normal limits.The er staff was instructed to decrease the vns pulse width by the patient's neurologist.After this adjustment, the patient reported having painful stimulation in her arm that radiated from the shoulder.The next day, the er staff reported that the patient might have had brachial nerve issues related to vns which contributed to the arm pain.The patient was put on steroids but the patient continued to report having painful shocks up her neck and arm.The patient was admitted a few days later for a battery replacement.This replacement had been planned as prophylactic before the patient reported painful stimulation, but the surgeon indicated that he had hoped the replacement would resolve the painful stimulation.Before this replacement, the patient continued to report painful arm stimulation, but also reported that she experienced painful stimulation in the chest.Diagnostics were again taken before replacement and results were within normal limits.After the replacement, the surgeon noted observing a lot of dense scar tissue around the leads where they connect to the generator.Further information was received that the patient continued to feel painful stimulation after the new generator was implanted.The patient's neurologist decided to disable the device in hopes that the nerve would "settle down".X-rays were reportedly taken and looked "good" according to the neurologist.The patient continued to report painful stimulation even with the device off.The neurologist reported that the patient had psychogenic issues and may have reported this painful stimulation for attention.The explanted generator was returned to the manufacturer for analysis, but analysis has not been completed to date.Both the replaced generator and newly implanted generator passed all quality inspections and electrical tests prior to being released for distribution.No further relevant information has been received to date.

Event Description

Further information was received from the patient's physician.The patient had returned to the clinic after the device had been off for some time.The patient reported that her previously reported pain and stimulation related issues had resolved with the device off.The physician reportedly believed that the vagus nerve may have been irritated by normal stimulation and needed a break from stimulation.The physician indicated diagnostic testing was still within normal limits although an exact impedance value was not provided.The patient returned to the clinic a few days later to have the vns turned back on.The patient then reportedly went through a security scanner at another department store some time after the device was turned back on.The patient reported that the vns was activated by this security scanner because she felt continuous and painful stimulation again.She reported the feeling was not inhibited by magnet disablement.She went to the hospital to have the device disabled.About a week later, she returned to the clinic where the device was turned back on by the physician.No additional relevant information has been received to date.

Event Description

Product analysis was completed on the explanted generator.There were no visual anomalies observed other than the typical marks and discoloration associated with implant and explant.The septum was not cored.The generator was successfully interrogated and system diagnostics were able to be performed.All results were normal for all tests performed.The battery voltage was measured during these tests and found to be functional.Additionally, the magnet functionality was tested.The pulse generator was programmed on the bench to the ¿as received¿ parameter settings, and an oscilloscope was attached at the outputs to monitor the current.The device output successfully stopped while the magnet was placed, and then successfully switched to the magnet current settings when removed.This confirmed the reed switch had been performing correctly.The generator was also tested in a simulated environment.The pulse generator was programmed to the ¿as received¿ parameter settings, and 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, with exception to the magnet swipes, and demonstrated that the device provided the expected level of output current for the entire monitoring period.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The data from the generator was also reviewed and did not contained any anomalies.The data showed that magnet activations were being performed leading up to the explant, but there was no indication of excessive swiping.There was no magnet data available from the day the patient began feeling continuous stimulation.Additional data from the more recently replaced generator has not been reviewed to date.No additional relevant information has been obtained to date.

Event Description

Information was received that the patient was turned on after walking through a security device at a grocery store and the device would not turn off.The device was subsequently disabled at an er.It was also reported that the neurologist did not want to turn the device back on as it could be hazardous to her health.Information was later received that the patient couldn't tolerate a 0.25 ma when the device was turned back on.At a later date, the patient was able to be turned on to 0.25ma for normal output current, but the magnet current was left off.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, 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: 7251316
• MDR Text Key: 99349024
• Report Number: 1644487-2018-00181
• 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,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2016
• Device Model Number: 104
• Device Lot Number: 4004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• 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: 30 YR