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

Model Number	303-20
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Convulsion, Clonic (2222); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was seen in clinic with high impedance.Ap chest x-rays were received and reviewed.The generator was not placed according to labeling, with the generator sitting anterior to rib 6.Based on the images provided, the feedthrough wires appear to be intact.The lead pin is fully inserted as the notch on the lead pin is seen equally between the first and second connector blocks.There is also not an excess amount of lead pin protruding from the first connector block.The entire portion of the lead was visualized, and no strain relief loop or bend were present.Tie downs are not visible and therefore not according to labeling.A portion of the lead was visualized to be behind the generator.The visible portions of the lead were assessed for fracture and discontinuities; however, none were noted.Based on the x-rays received, even though the device was not placed according to labelling, the cause of the malfunctions could not be determined; however, any fractures or microfractures on the portions of the lead that were not visible cannot be ruled out.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
Additional information received reporting that the patient experienced an increase in seizures (4 complex focal seizures per week).There were no falls reported for the patient.The patient had an electromyogram performed and the results were normal.There were no visible electrode fractures observed on the chest x-rays but the lead appeared to be taut due to the lack of a strain relief loop.The patient also reported that the generator was shifting position.The generator migration is captured in mfr.Report# 1644487-2026-10487.The patient then underwent surgery to have the full vns system removed.The explanted lead has not been received by product analysis 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): 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: 24408083
• Report Number: 1644487-2026-10237
• Device Sequence Number: 13198667
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 06/30/2026

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 Model Number: 303-20
• Device Lot Number: 1214
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 06/16/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/21/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown