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

Model Number	302-30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2023
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 livanovas 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 the patient was seen with high impedance pre-operatively.The generator was replaced and the high impedance was not resolved.No additional relevant information has been received to date.No surgical intervention has been reported to date for the patients leads.
Event or Problem Description
It was reported that the patient was referred for a lead revision.It was discovered that an employee from the manufacturer was aware of the event earlier than what was reported in the initial report.No known relevant surgical intervention regarding the suspect product has occurred to date.No other relevant information has been received to date.
Additional Manufacturer Narrative
B3.Date of event; initial mdr inadvertently included an incorrect event date b5.Describe event; corrected information; initial mdr inadvertently omitted information known prior to submission g3.Date received by manufacturer; initial mdr inadvertently included an incorrect aware date.
Additional Manufacturer Narrative
B3.Date of event; corrected information; sup mdr #1 inadvertently included the incorrect date of the event.
Event or Problem Description
It was reported that the patient recently had explant surgery instead of revising the lead.It is unknown what products were explanted.It was noted that following the battery replacement reported previously, the patient had their device disabled.The explanted device(s) have not been received to date.No other relevant information has been received to date.
Event or Problem Description
It was reported that the entire system was removed, the coils on the nerve were left behind.It was noted that the device was disabled as early as 10/10/2024.The suspect device has not been returned to the manufacturer to date.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 blvd; 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: 20757640
• Report Number: 1644487-2024-01476
• Device Sequence Number: 21205544
• Product Code: LYJ
• UDI-Device Identifier: 05425025750108
• UDI-Public: 05425025750108
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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,Followup
• Report Date (Section B): 03/25/2026

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: 01/20/2006
• Device Model Number: 302-30
• Device Lot Number: 010024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 01/07/2025; 02/05/2026; 02/27/2026
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/05/2024; 01/07/2025; 02/24/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2004
• 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: Female