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

Model Number	8103
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
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 during a generator replacement surgery, the new intended to be implanted generator was unable to be interrogated.The explanted generator was interrogated ok.After visual inspection of the new generator, a bulge was seen in the generator case.It was noted that the generator was stored according to labeling and there was no known damage during transport to or at the hospital.Device history records were reviewed and showed that the device passed final interrogation during manufacturing as well as all inspections and electrical tests.The suspect device has not been received by manufacturer to date.No other relevant information has been received to date.
Event or Problem Description
The suspect product was received by the manufacturer and is pending product analysis completion.
Event or Problem Description
Product analysis was completed on the suspect product.The generator would not communicate so an interrogation, a system diagnostic test, measured output voltage, vbatt calculation, and a comprehensive, automated electrical evaluation (fet) could not be performed.The generator was opened and the battery voltage was measured, 0.828v which confirmed an eos condition.A comprehensive, automated pcba electrical evaluation was performed.A bulge in the generator indicated a swollen battery.X-ray images showed loose foreign debris within the case, which is suspected to be a piece of excess feedthru wire.The excess wire caused the generator to have a short circuit, causing a rapid discharge of battery current.During manufacturing, excess feedthru wire is clipped off prior to soldering the battery to the pcba and the clippings are discarded.In this case, the clipping likely landed on the device following clipping and was not discarded.No communication was due to eos condition of the battery which appears to be caused by an internal short, high current event that drained/damaged the battery.There was no performance, or any other type of adverse conditions found with the pulse generator.Data dump was reviewed and no anomalies were observed.No additional anomalies were seen in the product analysis worksheet.

• Brand Name: SYMMETRY GEN MODEL 8103
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics boulevard; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 23996379
• Report Number: 1644487-2026-10033
• Device Sequence Number: 10509743
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2026

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: Health Professional
• Device Expiration Date: 03/27/2026
• Device Model Number: 8103
• Device Lot Number: 7870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 03/23/2026; 04/20/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 04/06/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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: 55 YR
• Patient Sex: Male