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

Model Number 104

Device Problems Energy Output To Patient Tissue Incorrect (1209); Premature End-of-Life Indicator (1480)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Cognitive Changes (2551)

Event Date 05/02/2018

Event Type  malfunction  

Event Description

It was reported by the company representative that she followed up to check a patient's device.(upon physician's request).The patient had recently been replaced and the new generator set to the same settings as the old generator.The patient experienced no issues post replacement.Upon interrogation, she observed a pop-up message upon interrogation that asked her to confirm settings.The patient responded very poorly when she accepted the settings.The patient began to cough profusely, shake and cry.The representative believed that the nonverbal patient was in pain.She said that the pain was definitely related to stimulation.The patient had to be turned all the way down until 0.25 ma output current from 2.75 ma until he could tolerate the settings.Per the company or support specialist's data, system diagnostics were within normal limits while the generator was in the pocket but before it was closed.No further interrogation or diagnostics were taken that day.Review of the internal data of the generator from the date that the company representative noticed the adverse events, it was determined that the patient's generator had become pulse-disabled due to eos-yes sometime within a day after the or support specialist performed system diagnostics mid-surgery.It is suspected that the patient's generator was hit with some sort of electrosurgerical tool or other electrostatic discharge during the last part of surgery.This causes the generator's voltage to drop below eos-yes threshold.Afterwards, the generator's voltage rebounds to expected voltage.Likely the patient reacted poorly to being set to 2.75 ma because his generator had been off for the 6 days post-surgically and had lost tolerance to high stimulation.It's important to note that the company or support specialist didn't know whether electrocautery was used, but that the company representative indicated that the surgeon was well-versed in the vns and knew not to use electrosurgical instruments after the generator was in the field.Operative notes from the patient's surgery was reviewed, and there was no evidence that electrosurgery was used after the vns was in the field.However, it was noted that the patient's pocket was extended after the final system diagnostics were run.Previously a photon blade was used to make a cut.It is unclear whether the photon blade was used to extend the pocket.No further relevant information has been received to date.

Event Description

The patient's generator was replaced prophylactically.Product return is not expected per historical hospital return policy.No further relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: the initial emdr did not originally report that the photon blade was likely an electrosurgical tool.Date received by manufacturer, corrected data: the aware date of 05/08/2018 was inadvertently reported as the aware date instead of 06/06/2018.

Event Description

Of note, it appears likely that the photon blade was an electrosurgical tool.

Event Description

It was reported that it was believed that the patient's generator was depleting faster than normal and the patient was referred for replacement.Data from the date low battery was originally found after implant (~(b)(6) 2018) was reviewed.Interrogation the generator was at eos-yes pulse-disabled; but voltage had rebound to normal limits.There was no evidence of a reboot and the pre-change/post-change impedance values was within normal limits.Per clinic notes, in (b)(4) 2019, battery life was as expected at 75-100% battery life, but in (b)(4) 2019, it was found to be 18-25% battery remaining.It should be noted that asic latch-up condition (which can be caused by electrosurgical tools as noted in the initial mdr) is known to lead to premature battery depletion, where the generator typically depletes approximately twice as fast.Therefore, this premature depletion is not unexpected.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7575640
• MDR Text Key: 110454376
• Report Number: 1644487-2018-00985
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/29/2019
• Device Model Number: 104
• Device Lot Number: 204365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/04/2018; 08/13/2019; 10/23/2019
• Supplement Dates FDA Received: 07/04/2018; 09/06/2019; 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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: 31 YR