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

Model Number	302-20
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was seen with high impedance after a recent battery replacement.The patient had x-rays taken.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
Further update by the treating physician revealed that there was no reported trauma to device area or manipulation.Patient underwent lead replacement surgery.No other relevant information has been received to date.
Event or Problem Description
Additional information received noting that the patient was brought back into surgery.The surgeon re-inserted the lead pin and performed a system diagnostic, and the impedance was within normal limits.The patient was then seen again afterwards with high impedance, so the physician now assumes that there is a lead break.The patient has been referred for a lead revision.No known lead revision has occurred to date.No other relevant information has been received to date.
Additional Manufacturer Narrative
B5, corrected data: the initial report was inadvertently submitted without providing the assessment of provided x-rays.This field has been updated to the date of this correction submission for the purposes of this report.
Event or Problem Description
Ap chest x-rays were received and reviewed.The x-rays were provided after a report of a high impedance error was received after running system diagnostics.Generator placement was observed to be according to labeling, with the generator sitting below the clavicle in the left chest.Based on the images provided, the feedthrough wires appear to be intact, and the lead pin does appear to be fully inserted past the second connector block.The entire portion of the lead could not be visualized, and strain relief loops and bends could not be assessed.Tie-downs were not visible due to the scope of the images provided.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.While there are no sharp angles, there does appear to be some looping of the lead adjacent to the generator and connector pin.The lead is not fractured.Based on the x-rays received, the cause of the high impedance 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.

• 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): 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: 24568059
• Report Number: 1644487-2026-10315
• Device Sequence Number: 8384573
• 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: 2004
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/01/2026

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 Expiration Date: 12/03/2005
• Device Model Number: 302-20
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 04/14/2026; 05/07/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/06/2026; 05/07/2026; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 66 YR
• Patient Sex: Male