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

Model Number	302-20
Medical Device Problem Codes	Corroded (1131); High impedance (1291)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
Event or Problem Description
It was reported that a few weeks after their replacement, they started experiencing pain in the neck.During their appointment with the provider impedance was suspected to be high.X-rays have been ordered.Patient has been referred to surgery for potential replacement.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Additional Manufacturer Narrative
H6: types of investigation: initial report inadvertently did not code b20.
Event or Problem Description
Additional information received.It was noted that the patients lead was replaced.The suspected device has not been returned to the manufacturer to date.No other relevant information has been received to date.
Event or Problem Description
It was later reported that the patient was hospitalized for three days after lead replacement and was informed that the silicone lining of the lead was deteriorating in her neck, which reportedly explained the thinner appearance of the lead on x-ray.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 24028329
• Report Number: 1644487-2026-10060
• Device Sequence Number: 9502094
• Product Code: LYJ
• UDI-Device Identifier: 05425025750092
• UDI-Public: 05425025750092
• Combination Product (Y/N): N
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/18/2011
• Device Model Number: 302-20
• Device Lot Number: 200841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 02/02/2026; 02/12/2026; 03/31/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/02/2026; 03/09/2026; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2008
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female