MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Asystole (4442)

Event Date 10/11/2023

Event Type  Injury  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that asystole occurred for the patient for one second when system diagnostics was performed right after wound closure.Once the system diagnostics test completed, the patient's heart rate recovered.Prior to that, no problem had occurred when a stimulation test was performed before the wound closure.The physician lowered the patient's pulsewidth from 500usec to 250usec and multiple system diagnostic test were performed at various output currents.For 0.25ma and 0.5 ma, there were no issues seen but for 0.75ma and 1 ma the patient's heart rate slowed down a bit.Since no further events of cardiac arrest/asystole occurred, the physician concluded that the vns was usable as long as the output current was set to 1ma or below.No device malfunction was suspected.No other relevant information has been received to date.

Event Description

The patient experienced asystole on (b)(6) 2023 during system diagnostics when the output current was set to 1ma.Deep anesthesia was used during the surgery and the surgery lasted for 2 hours and the device was able to be implanted.The patient does not have any abnormal vagal anatomy and the device was confirmed to have been functioning as intended and the asystole was assessed to be related to vns stimulation.It was also noted that the patient's settings were increased to 1.25ma and the situation is being monitored.

• Brand Name: PULSE GEN MODEL 106
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18065212
• MDR Text Key: 327282650
• Report Number: 1644487-2023-01584
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106
• Device Lot Number: 206089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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): Life Threatening
• Patient Age: 48 YR