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 Aspiration/Inhalation (1725); Skin Infection (4544)

Event Date 05/26/2023

Event Type  Injury  

Event Description

It was reported that the patient had a generator explant due to infection of the left chest pocket.The device was to be disconnected from the lead to preserve potential for re-implantation post healing.Dhr for the generator performed.The generator was confirmed to have been hp sterilized prior to distribution into the field.The device passed all specifications.No other relevant information has been received to date.

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 livanovas 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.H3.Code 81 - device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

Event Description

The physician was referring to an aspiration test to determine if infection is present.The patient did not aspirate.

Manufacturer Narrative

B5.Corrected event description, supplemental #1 report.Inadvertently described aspiration incorrectly.

Event Description

The patient's physician later reported that the cause of infection is unknown, but that it was first observed based on aspiration.No other relevant information has been received to date.

Event Description

It was previously reported that the lead would remain implanted for when a future generator was to be implanted.This is no longer the plan, the patient is now referred for surgery to remove their lead.

Event Description

It was later confirmed that the patient had their lead removed on (b)(6) 2023.The explanted lead is unavailable for return to the manufacturer indicating that it was likely discarded.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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17278700
• MDR Text Key: 318582065
• Report Number: 1644487-2023-00875
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• 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: 7260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2022
• 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): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female