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

Model Number	106
Medical Device Problem Codes	Premature Discharge of Battery (1057); Premature Elective Replacement Indicator (1483); Battery Problem: High Impedance (2947)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information received.The patients battery status has rebounded.Confirmed by session report.The battery rebound event was confirmed to be related to a known event cause by the impedance behaviors in the beginning of the battery's life.Internal investigation identified that in some cases, pulse generators reach the 25% battery indicator earlier than expected and later rebound without any significant programming changes.This behavior was determined to be due to an increased duration of high battery impedance during generator battery beginning-of-life.There is no evidence of a device malfunction.No other relevant information has been received to date.

• 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): LivaNova USA, Inc.; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX ; +1(866)882-8804
• MDR Report Key: 50240428
• Report Number: 1644487-2026-10953
• Device Sequence Number: 10374053
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 106
• Device Lot Number: 1066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2025
• 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: 50 YR
• Patient Sex: Female