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	Suicidal Ideation (4429)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had experienced an adverse event of worsening of suicidal ideation.This event as assessed as possibly related to stimulation and not related to procedure or presence of device.The event did meet serious adverse event criteria and is still is considered an ongoing issue.Later, the study reconciliation report was reviewed.The worsening of suicidal ideation was noted to have resulted in a hospitalization.This event is considered 'severe' and noted to be ongoing.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; houston TX 77058
• Manufacturer (Section G): Houston; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics boulevard; suite 600; houston, TX 77058 ; +1(281)667-2681
• MDR Report Key: 50550093
• Report Number: 1644487-2026-11026
• Device Sequence Number: 10265903
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 03/23/2022
• Device Model Number: 8103
• 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: 08/07/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2020
• 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: Hospitalization
• Patient Age: 33 YR
• Patient Sex: Female