MAUDE Adverse Event Report: LivaNova USA, Inc. Pulse Gen Model 106; Generator

Model Number	106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant card received noting that the patient underwent a generator replacement due to stimulation not being consistent.The explanted generator has not been received by product analysis to date.No other relevant information has been received to date.
Additional Manufacturer Narrative
H6 adverse event problem codes, clinical code: code e2402 utilized; appropriate term ¿erratic stimulation¿ is not available.

• Brand Name: Pulse Gen Model 106
• Common Device Name: Generator
• Manufacturer (Section D): LivaNova USA, Inc.; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): Houston; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; +1(281)667-2681
• MDR Report Key: 50867388
• Report Number: 1644487-2026-11117
• Device Sequence Number: 10743092
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/05/2024
• Device Model Number: 106
• Device Lot Number: 7208
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 YR
• Patient Sex: Female