MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number	302-20
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was seen with high impedance.Xrays were taken and no lead issues were identified.The patient has been scheduled for a follow up and will be referred for a revision if the high impedance persists.X-rays have not been reviewed by the manufacturer to date.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 noting that no intervention has been planned to date for the high impedance as right now the patient's seizures are at baseline.It was also confirmed that the lead pin was fully inserted past the second connector block, the setscrew was fully tightened, and the impedance was good at the time of implant.

• Brand Name: LEAD MODEL 302
• Common Device Name: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer (Section G): HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 24284955
• Report Number: 1644487-2026-10191
• Device Sequence Number: 15918272
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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: Lay User/Patient
• Device Expiration Date: 10/03/2010
• Device Model Number: 302-20
• Device Lot Number: 200631
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 05/15/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/12/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2007
• 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: 57 YR
• Patient Sex: Male