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	08/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patients output current was not being delivered, and lead impedance was >9,000 ohms, suggesting a possible lead discontinuity or hardware malfunction.Chest and neck x-rays were ordered to assess for lead damage or fracture.The patient reported recent attendance at a fair where ride restraints may have applied pressure over the implant site, potentially contributing to device- or lead-related trauma.Due to the diagnostic findings and concern for lead failure, surgical exploration with possible lead revision or replacement was scheduled.It was later noted that the x-rays were not available for review.The provider noted that the pin was fully inserted and that there was no visible lead break.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; +1(281)667-2681
• MDR Report Key: 50804266
• Report Number: 1644487-2026-11090
• Device Sequence Number: 20993645
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/17/2026

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: 01/06/2023
• Device Model Number: 304-20 HP
• Device Lot Number: 204757
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2019
• 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: 36 YR
• Patient Sex: Female