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

Model Number	302-20
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was seen with high impedance and low output.Ap chest x-rays were received on (b)(6) 2026 and reviewed by cqe (b)(6) on (b)(6) 2026 and approved by cqe (b)(6) on (b)(6) 2026.The x-rays were provided after a report of high impedance and low output current.Generator placement was observed to be according to labeling, with the generator sitting in the left chest, below the clavicle.Based on the images provided, the feedthrough wires were intact, and the lead pin is fully inserted as the end of the pin can be seen past the second connector block.The entire portion of the lead can be visualized, and a strain relief loop and bend are present, both placed per labeling.Only one tie down is visible, placed laterally from the anchor tether.A portion of the lead was visualized to be behind the generator.The visible portions of the lead were assessed for fracture and discontinuities; however, none were noted.Based on the x-rays received, the cause of the malfunctions could not be determined; however, any fractures or microfractures on the portions of the lead that were not visible cannot be ruled out.No other relevant information has been received by the manufacturer to date.No surgical intervention has occurred to date.

• Brand Name: LEAD MODEL 302
• Common Device Name: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics boulevard; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 25076688
• Report Number: 1644487-2026-10554
• Device Sequence Number: 21516461
• Product Code: LYJ
• UDI-Device Identifier: 05425025750092
• UDI-Public: 05425025750092
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 10/07/2005
• Device Model Number: 302-20
• Device Lot Number: 9307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2003
• 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: 48 YR
• Patient Sex: Female