MAUDE Adverse Event Report: HOUSTON GENERATOR MODEL 104

Model Number	104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion, Clonic (2222)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A response was received regarding the manufacturer's good faith attempt questions.It was determined that the increase in seizures was due to ¿low battery¿ and ¿external factors¿.The patient¿s seizure rate was confirmed to be above the pre-vns baseline levels.Later, an implant card was received indicating that the patient's generator was replaced due to battery depletion.The explanted device has not been received by the manufacturer to date.No other relevant information has been received to date.
Event or Problem Description
It was reported that the patient was in need of an urgent battery referral.The patient was reported to have experienced multiple seizures within 24 hours after trauma to head while at work.The patient's battery was noted to be low upon interrogation the patient was urgently referred for replacement as a result.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
The suspect product has been received by the manufacturer and is currently undergoing analysis.No other relevant information has been received to date.
Event or Problem Description
Product analysis testing on the generator was completed.No anomalies were detected during testing.No other relevant information has been received to date.

• Brand Name: GENERATOR MODEL 104
• 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: 24170985
• Report Number: 1644487-2026-10141
• Device Sequence Number: 15996972
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/27/2026

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: 12/01/2013
• Device Model Number: 104
• Device Lot Number: 3220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 03/23/2026; 05/20/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/19/2026; 04/17/2026; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male