MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number	304-20 HP
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was seen with high impedance.The patient and the patient's mother had declined any recent falls or trauma to the area.The lead impedance was >=9,000 ohms with a warning sign.It was later reported that no x-rays were preformed and that revision surgery is planned.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• 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; 2816672681
• MDR Report Key: 25599958
• Report Number: 1644487-2026-10757
• Device Sequence Number: 9802029
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/23/2026

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 Model Number: 304-20 HP
• Device Lot Number: 954
• 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: 05/29/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• 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: 17 YR
• Patient Sex: Male