MAUDE Adverse Event Report: HOUSTON GENERATOR MODEL 1000-D

Model Number	GENERATOR, MODEL 1000-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Status Epilepticus (4408)
Date of Event	04/06/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient had passed away due to status epilepticus.The physician did not believe that this death was related to vns.No other relevant information has been received to date.
Event or Problem Description
A death follow-up form was sent to the patent's managing physician.The completed form was filled out and revealed the following surrounding the event: the physician re-iterates that the patient passed away from status epilepticus.The patient's response to vns therapy was a seizure reduction/seizure free.Both the generator and lead were explanted after death and have not been received by the manufacturer to date.The relationship of death to the vns was determined to be not related.When the patient was found dead, they were noted to be laying on the floor with their head [illegible].The patient did have a history of nocturnal seizures.
Additional Manufacturer Narrative
B3.Date of event; corrected information; inadvertently included incorrect information initial report.H4.Device manufacture date; corrected information; inadvertently left off of initial report despite being known at the time of submission.D4.Lot#; corrected information; inadvertently included incorrect information initial report.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.

• Brand Name: GENERATOR MODEL 1000-D
• Common Device Name: GENERATOR
• 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: 21954149
• Report Number: 1644487-2025-10086
• Device Sequence Number: 20970741
• Product Code: LYJ
• UDI-Device Identifier: 05425025750528
• UDI-Public: 05425025750528
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2025

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?: No
• Device Expiration Date: 08/26/2026
• Device Model Number: GENERATOR, MODEL 1000-D
• Device Lot Number: 206384
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 11/21/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 07/09/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Sex: Male