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	Convulsion, Clonic (2222)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
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 since replacement, the patient has had a significant increase in seizures.The patient also reported that they can no longer perceive stimulation.The patient was sent to the emergency room as a result.No other relevant information has been received to date.
Event or Problem Description
The patient and physician determined that the increase in seizures was likely a increase in stress from the surgery/anesthesia, and a respiratory infection she was fighting at the time.The neuro classified this as "not related to vns".The increase in seizure rate was noted to be above their pre-vns baseline levels.

• 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: 22206816
• Report Number: 1644487-2025-10254
• Device Sequence Number: 7723138
• Product Code: LYJ
• UDI-Device Identifier: 05425025750528
• UDI-Public: 05425025750528
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: GENERATOR, MODEL 1000-D
• Device Lot Number: 960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 07/17/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/02/2025; 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female