MAUDE Adverse Event Report: LivaNova USA, Inc. Pulse Gen Model 1000; Generator

Model Number	1000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was seen with an infection.Device history records were reviewed for the generator and lead.The generator and lead passed all specifications prior to distribution.The generator and lead were hp sterilized.No other relevant information has been received to date.

• Brand Name: Pulse Gen Model 1000
• 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 77058 ; +1(281)667-2681
• MDR Report Key: 50843169
• Report Number: 1644487-2026-11110
• Device Sequence Number: 9949820
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: Health Professional
• Device Model Number: 1000
• Device Lot Number: 1069
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 YR
• Patient Sex: Female