MAUDE Adverse Event Report: LIVANOVA USA, INC. PROGRAMMING SOFTWARE

Model Number	3000
Medical Device Problem Codes	Application Program Problem: Parameter Calculation Error (1449); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during follow up, the patient's duty cycle was adjusted from 35% to 38% for day settings with no issues.When trying to do the same adjustment for nighttime settings, an error appeared.System diagnostics were performed, and an error was seen regarding low output current.Day/night settings were disabled, and the error went away.Internal generator data was received but have not been reviewed.No other relevant information has been received to date.
Additional Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 cfr 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 or Problem Description
Internal data reviewed.
Event or Problem Description
It was later found that the patients vns was programed at 11:26 am where daytime duty cycle was changed.The vns was then programed at 11:27 am where nighttime duty cycle was changed.When a generators day/night mode is turned on, there is a 15-minute temporary test window.When the device is programmed again within that 15-minute test window, it typically causes a false output current reading.No other relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics boulevard; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 21778619
• Report Number: 1644487-2025-10018
• Device Sequence Number: 8593503
• Product Code: LYJ
• UDI-Device Identifier: 05425025750535
• UDI-Public: 05425025750535
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3000
• Device Lot Number: 206050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 07/21/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/09/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown