MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number	102 HP
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The patient was scheduled for a battery replacement, and during pre-op checks, the vns device showed as disabled at 0 ma output current.The rep initially assumed this was intentional, but in the operating room, the surgeon confirmed they had checked the battery weeks earlier and had not disabled therapy or changed settings.The replacement proceeded normally, and afterward, the rep reviewed the physician¿s tablet and confirmed no changes had been made in prior sessions.Both the rep and surgeon are unsure if the patient had an mri or other procedures requiring therapy to be disabled.Diagnostics were normal, and the battery status was ok.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): HOUSTON; 100 cyberonics boulevard; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 23930877
• Report Number: 1644487-2025-11028
• Device Sequence Number: 9041522
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (Y/N): N
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: Lay User/Patient
• Device Expiration Date: 01/27/2018
• Device Model Number: 102 HP
• Device Lot Number: 4738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2016
• 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 Age: 37 YR
• Patient Sex: Female