MAUDE Adverse Event Report: HOUSTON SYMMETRY GEN MODEL 8103; GENERATOR

Model Number	8103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breathing-related sleep disorder (4875)
Date of Event	06/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction h6 impact code: f2301 was inadvertently left off the initial report and has now been added.
Event or Problem Description
It was reported that the subject was experiencing sleep apnea possibly related to stimulation and possibly related to the device.The subject has been placed on cpap machine and is not experiencing a serious deterioration in health.The event has not resolved or recovered.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: SYMMETRY GEN MODEL 8103
• Common Device Name: GENERATOR
• Manufacturer (Section D): HOUSTON; 100 cyberonics boulevard; suite 600; 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 ; 2816672681
• MDR Report Key: 24782094
• Report Number: 1644487-2026-10418
• Device Sequence Number: 15934031
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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: 10/12/2023
• Device Model Number: 8103
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2021
• 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: Life Threatening
• Patient Age: 68 YR
• Patient Sex: Female