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

Model Number	302-20
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was seen in clinic with high impedance.The patient has been referred for x-rays.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Additional Manufacturer Narrative
D4 lot number, corrected data: initial report inadvertently did not provide the lot number h4 device manufacture date, corrected data: initial report inadvertently did not provide the manufacture date.

• 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: 24656588
• Report Number: 1644487-2026-10360
• Device Sequence Number: 5117220
• Product Code: LYJ
• UDI-Device Identifier: 05425025750092
• UDI-Public: 05425025750092
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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
• Report Date (Section B): 04/30/2026

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: 02/14/2008
• Device Model Number: 302-20
• Device Lot Number: 929
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/21/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2005
• 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: 27 YR
• Patient Sex: Female