MAUDE Adverse Event Report: Houston Pulse Gen Model 103; Generator

Model Number	103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Convulsion, Clonic (2222); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction

• Brand Name: Pulse Gen Model 103
• Common Device Name: Generator
• Manufacturer (Section D): Houston; 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: 50847629
• Report Number: 1644487-2026-11111
• Device Sequence Number: 9508009
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/22/2016
• Device Model Number: 103
• Device Lot Number: 4130
• 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: 08/30/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2014
• 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: 74 YR
• Patient Sex: Female