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

Model Number	302-20
Medical Device Problem Codes	Low impedance (2285); Electrical Shorting (2926); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a patient's generator replacement, low impedance was observed after the new generator was attached to the patient's leads.The surgeon indicated they observed a fracture in the plastic of the lead.It is unknown if the fracture was limited to the outer tubing or if inner and outer tubing were fractured.Additional information was received that the patient was rescheduled for lead revision and that the patient's leads were replaced.The suspect product has not been received by the manufacturer to date.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Common Device Name: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics boulevard; 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: 25058683
• Report Number: 1644487-2026-10542
• Device Sequence Number: 10100673
• Product Code: LYJ
• UDI-Device Identifier: 05425025750092
• UDI-Public: 05425025750092
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: Health Professional
• Device Expiration Date: 01/04/2006
• Device Model Number: 302-20
• Device Lot Number: 009894
• 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: 04/07/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2004
• 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: 58 YR
• Patient Sex: Male