MAUDE Adverse Event Report: HOUSTON LEAD MODEL 302

Model Number	303-20
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Convulsion, Clonic (2222); Depression (2361)
Date of Event	01/01/2025
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 patient had been experiencing changes in their seizure frequency and type, and increased depression, which they attributed to their vns starting to die.Later it was reported that the patient underwent generator replacement surgery.The generator was unable to interrogate suspected to be due to eos.Once a new generator was implanted high impedance was seen.It was noted that during surgery, pin insertion troubleshooting was performed but did not resolve high impedance.A test resistor was offered.However, due to risk of infection, the surgeon did not want to wait for test resistor.It was decided by the surgeon to close the patient.The device was not programmed on.Tablet data was provided and reviewed and no anomalies outside of the high impedance condition were seen.Based on the new information regarding high impedance, it can be reasonably assumed that this high impedance condition was present on the previous generator and resulted in an expected accelerated depletion of the generator.This failure to program is likely a result of this accelerated depletion.In turn this end of service = yes state of the generator could have reasonably attributed to the patient's seizure frequency and type, and increased depression.Later a response was received from the provider.The provider was unable to provide any assessments to the cause of the adverse events reported by the patient.Instead of providing a cause, the provider indicated "na" - this will conservatively be interpreted to mean that the provider was either not aware of these adverse events (since this was reported directly by the patient) or is unsure on the cause of these events.However, it was reported that the patient did not experience a change in their seizure type.No other relevant information has been received to date.The suspect device remains implanted to date.
Event or Problem Description
Additional information was received indicating that the patient underwent a lead revision due to the high impedance reported.The explanted lead has not been received to date.

• Brand Name: LEAD MODEL 302
• Common Device Name: LEAD
• Manufacturer (Section D): HOUSTON; 100 cyberonics boulevard; 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: 22913770
• Report Number: 1644487-2025-10556
• Device Sequence Number: 9266575
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 09/21/2020
• Device Model Number: 303-20
• Device Lot Number: 203926
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female