MAUDE Adverse Event Report: HOUSTON LEAD MODEL 302

Model Number	302-20
Medical Device Problem Codes	Fracture (1260); Device Contamination with Body Fluid (2317); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient passed away due to severe anoxic brain injury, generalized seizures, intractable status epilepticus and lennox-gastaut syndrome.The devices were explanted and returned for product analysis.A failure was observed during the analysis of the returned lead, it is not believed to be related to the reported death.The reported death is investigated and reported on manufacturing report number 1644487-2025-10713.This report will capture the observed lead issues.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Common Device Name: LEAD
• Manufacturer (Section D): HOUSTON; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics boulevard; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 24564168
• Report Number: 1644487-2026-10314
• Device Sequence Number: 15668579
• Product Code: LYJ
• UDI-Device Identifier: 05425025750092
• UDI-Public: 05425025750092
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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: 12/01/2006
• Device Model Number: 302-20
• Device Lot Number: 11608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2004
• 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: 25 YR
• Patient Sex: Female