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 Problems Bradycardia (1751); Asystole (4442)

Event Date 11/22/2022

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

On (b)(6) 2022, full replacement was performed for patient.During the surgery, the patient experienced bradycardia and cardiac arrest at the time of stimulation tests with new generator and lead.Therefore the new generator and lead were not implanted.Bradycardia and cardiac arrest occurred when the patient was given a test stimulation of 1.0 ma with new m106 (s/n (b)(4)) and lead m304-20 (s/n (b)(4)).It was originally 85 bpm to 90 bpm, but dropped to around 60 bpm during testing.Cardiac arrest occurred when test stimulation was performed again at 2.75ma.Therefore, transcutaneous pacing was performed.When the lead coil was moved in the caudal direction and test stimulation was performed again at 1.0 ma, cardiac arrest occurred again, and percutaneous pacing was performed again.Physicians determined that it would be difficult to complete the implant in this situation.He removed the new generator and lead from the patient body and closed the wound.The products are scheduled for return and confirmed shipped but have not been received to date.Device history records were reviewed.The devices were confirmed to have passed all functional and quality tests and were hp sterilized prior to distribution.No other relevant information has been received to date.This mdr houses the report of arrythmia asystole and arrythmia bradycardia on the generator that was not implanted.

Event Description

The device has been received into product analysis.Product analysis is underway but not yet completed.No other relevant information has been received to date.

Event Description

The physician has reported that the events are believed to be related to vns stimulation, that the device was functioning as intended, it was used as usual, and no particular problems occurred with the device.Intervention was taken using percutaneous pacing and the patient was not hospitalized.The event has not recurred.Arrhythmia events related to vns stimulation are a known inherent risk of the device addressed in labeling.No other relevant information has been received to date.

Event Description

Generator product analysis was approved for the device.There were no performance, or any other type of adverse conditions found with the pulse generator.No anomalies were seen, and the device performed according to functional specifications.No other relevant information has been received to date.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16000132
• MDR Text Key: 305685776
• Report Number: 1644487-2022-01565
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2024
• Device Model Number: 106
• Device Lot Number: 7240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• 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: 48 YR
• Patient Sex: Male