MAUDE Adverse Event Report: HOUSTON GENERATOR MODEL 104; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number	GENERATOR, MODEL 104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fluid Discharge (2686); Unspecified Tissue Injury (4559); Peripheral Edema (4578)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was scheduled for generator explant due to the device protruding from her body.Later an update was received indicating that the patient's generator was successfully removed.The lead remained implanted.There is no information regarding a future replacement at this time.The explanted suspect device has not been received by the manufacturer to date.No other relevant information has been received to date.
Event or Problem Description
Later, an update was received indicating that extrusion of the generator was seen rather than protrusion.This extrusion was preceded by "sticky" drainage.The mother stated that the stimulator has progressively emerged more and more over the course of several days.The generator was explanted as a result.The lead remains implanted.During the explant of the generator, no incision was necessary since the generator was hanging out of the wound the generator.Cultures were obtained and the wound was then copiously irrigated.Device history records were reviewed for the generator and lead.The generator and lead passed all specifications prior to distribution.The generator and lead were hp sterilized.The explanted generator has not been received by the manufacturer to date.No other relevant information has been received to date.

• Brand Name: GENERATOR MODEL 104
• Common Device Name: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• 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: 25060981
• Report Number: 1644487-2026-10549
• Device Sequence Number: 15791258
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: GENERATOR, MODEL 104
• Device Lot Number: 204706
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female