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

Model Number	304-30 HP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The suspected product was returned due to unknown reason.Internal data review showed that the device experiencing high impedance on 01/31/2024.Since the explant date of the device is unknown.High impedance/fracture of lead will be captured.Product analysis was completed and reviewed; no anomalies was seen.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; houston, TX 77058 ; 2816672681
• MDR Report Key: 24743363
• Report Number: 1644487-2026-10394
• Device Sequence Number: 9230382
• Product Code: LYJ
• UDI-Device Identifier: 05425025750153
• UDI-Public: 05425025750153
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 04/26/2020
• Device Model Number: 304-30 HP
• Device Lot Number: 203776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2016
• 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: 31 YR
• Patient Sex: Female