MAUDE Adverse Event Report: LivaNova USA, Inc. Lead Model 302

Model Number	302-30
Medical Device Problem Codes	Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317); Naturally Worn (2988)
Health Effect - Clinical Code	Convulsion, Clonic (2222)
Date of Event	05/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was referred for potential full revision.It was later noted that the patient was seen by the representative and inconsistent impedance ws seen.It was later reported that on (b)(6) 2026 due to high lead impedance that had been identified more than two months earlier.During surgery, the original generator was replaced, but impedance remained elevated (approximately 5,600 ohms).After freeing and inspecting the lead within the chest pocket, impedance increased further to approximately 6,900 ohms.The lead was observed to have discoloration of the outer coating (corrosion), along with fluid accumulation and fibrotic/scar tissue in the pocket (fluid leak and tissue growth).Based on these findings, the surgeon elected to replace the lead without additional troubleshooting.Following implantation of the new lead and generator, system diagnostics showed a normal impedance of approximately 1,130 ohms.The explanted devices were retained by the hospital and subsequently discarded, making return and further analysis unavailable.The patient reportedly experienced increased seizure activity suspected to be due to high impedance.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; +1(281)667-2681
• MDR Report Key: 50456878
• Report Number: 1644487-2026-11001
• Device Sequence Number: 10319870
• Product Code: LYJ
• UDI-Device Identifier: 05425025750108
• UDI-Public: 05425025750108
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• 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
• Report Date (Section B): 08/26/2026

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: 08/09/2008
• Device Model Number: 302-30
• Device Lot Number: 1239
• 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: 07/01/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2005
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male