MAUDE Adverse Event Report: HOUSTON LEAD MODEL 304

Model Number	304-30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had normal impedance prior to their mri and high impedance post mri.Data from the generator was received and reviewed.It was discovered that the impedance onset was seen several months before the mri was completed.The generator had showed a behavior of intermittent impedance issues, with the system periodically switching between high and normal impedance values.This is often indicative of a positional lead fracture.A preliminary review of x-rays could not identify any anomalies occurring within the system.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): HOUSTON; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): HOUSTON; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 25318922
• Report Number: 1644487-2026-10647
• Device Sequence Number: 20175414
• Product Code: LYJ
• UDI-Device Identifier: 05425025750153
• UDI-Public: 05425025750153
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: Lay User/Patient
• Device Model Number: 304-30
• Device Lot Number: 206014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Female