MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number	302-20
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a routine follow up, high impedance was seen.X-ray was taken for patient.It was confirmed that the patient did not experience any trauma.Patient has been referred for consultation.It was confirmed that procedures were follow to ensure the lead pin was fully inserted into the generator.No surgical intervention has been performed to date.No additional relevant information has been received to date.
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 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
X-rays were later received and reviewed.No surgical intervention has been performed to date.No additional relevant information has been received to date.
Event or Problem Description
After the x-ray was preformed and incomplete pin insertion was confirmed.X-ray review could not identify any micro fractures of the lead due to poor x-ray quality.Exploratory surgery was performed where the lead was re-inserted into the generator.This did not resolve the impedance issue.Generator was tested with the test resistor impedance was within normal limit.Replacement surgery for the lead will be performed.No surgical intervention has been performed to date.No additional relevant information has been received to date.
Event or Problem Description
It was later reported that the patient underwent lead replacement.The surgeon noted that the was signs of weaking and discontinuity along one the electrode.The explanted device is not available for return as it was discarded.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Common Device Name: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 21354979
• Report Number: 1644487-2025-00146
• Device Sequence Number: 9078560
• Product Code: LYJ
• UDI-Device Identifier: 05425025750108
• UDI-Public: 05425025750108
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/07/2025

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: Health Professional
• Device Expiration Date: 10/07/2010
• Device Model Number: 302-20
• Device Lot Number: 200635
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: Not provided; 05/13/2025; 09/15/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/01/2025; 06/05/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2007
• 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: 20 YR
• Patient Sex: Female