MAUDE Adverse Event Report: LIVANOVA USA, INC. SYMMETRY GEN MODEL 8103; GENERATOR

Model Number	8103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Suicidal Ideation (4429); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
Event or Problem Description
It was reported that the patient experienced suicidality - self harm.Adverse event is not listed as a serious adverse event, reported to be moderate, not related to implant / procedure and with causal relationship to stimulation/device.Outcome is recovered/ resolved.The patient's treatment was not changed due to this adverse event.The only action taken was observation.No other relevant information has been received to date.
Event or Problem Description
Additional information received.The device history record was later provided for the suspected product.No other relevant information has been received to date.
Additional Manufacturer Narrative
H6 health effect, clinical code: code e2402 utilized; appropriate term "suicide attempt" is not available.
Event or Problem Description
Additional information received.It was later reported that the patient attempted suicide, started date, and relationship to vns is unknown.The outcome of the event is also unknown.No other relevant information has been received to date.
Event or Problem Description
It was later reported that the initial report of self-harm was noted to have occurred prior to vns implant therefore it will be considered as not related to vns.No other relevant information has been received to date.
Event or Problem Description
It was later reported that the patient was still in the hospital due to adverse event.No other relevant information has been received to date.

• Brand Name: SYMMETRY GEN MODEL 8103
• 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 ; 2816672681
• MDR Report Key: 23906894
• Report Number: 1644487-2025-11012
• Device Sequence Number: 18381351
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/11/2026

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: 06/27/2025
• Device Model Number: 8103
• Device Lot Number: 7641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 03/20/2026; 04/15/2026; 05/21/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/14/2026; 04/14/2026; 05/06/2026; 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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: 46 YR
• Patient Sex: Female