MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number	303-20
Medical Device Problem Codes	Low impedance (2285); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Discomfort (2330); Neck Pain (2433); Shock from Patient Lead(s) (3162); Cramp(s) /Muscle Spasm(s) (4521); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented with painful stimulation and muscle spasms of the jaw, eyes, forehead, and neck.The patient reportedly felt like her head and eyes were bulging.The physician disabled the device but the patient reportedly felt stimulation despite the device disablement.The physician reportedly saw a low impedance warning message despite lead impedances values being within normal limits.The patient was admitted to the hospital and was seen by the epilepsy nurses.The patient's vns was later re-enabled.Diagnostics are within normal limits.A review of device history records showed that the lead passed quality control inspection and was sterilized prior to distribution.No surgical intervention has occurred to date.No additional relevant information has been received to date.
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
An update on this event was received from the company representative.The reported low impedance never occurred.Impedances were never out of range.Impedances were lower than a previous impedance test, with values of 2475 ohms and 2529 ohms, but this is well within normal limits.The cause of the adverse events reported were due to the patient's history of mental health issues.The epilepsy center that works with the patient indicated that this is a common occurrence due to their medical history and these events were not occurring with the device.It was again confirmed that there is no malfunction of the device and all the adverse events reported were related to their mental health issues which they did not relate to the vns device.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• Common Device Name: LEAD
• 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 blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 22550386
• Report Number: 1644487-2025-10388
• Device Sequence Number: 9237595
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/19/2021
• Device Model Number: 303-20
• Device Lot Number: 204097
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 07/19/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2017
• 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