MAUDE Adverse Event Report: Houston Generator Model 106

Model Number	106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient had their vns therapy system explanted for an unknown reason.Later, a response was received from the provider indicating that the patient's generator was explanted due to generator site pain.It was noted that no replacement product will be implanted.\ \ no other relevant information has been received to date.\ the explanted device has not been received by the manufacturer to date.

• Brand Name: Generator Model 106
• 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 boulevard; suite 600; houston, TX 77058 ; +1(281)667-2681
• MDR Report Key: 50830377
• Report Number: 1644487-2026-11107
• Device Sequence Number: 10247968
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: Lay User/Patient
• Device Expiration Date: 09/15/2018
• Device Model Number: 106
• Device Lot Number: 5044
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female