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	Medical device site infection (4845)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was scheduled for explant of generator and lead due to infection.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.Later it was confirmed that the devices were explanted.It was reported that the explanted devices will not be available for return to the manufacturer due to hospital protocol.Please note that device evaluation is not necessary because the reported event has been determined to not be related to the functionality of the device.No other relevant information has been received 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 blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 25782382
• Report Number: 1644487-2026-10812
• Device Sequence Number: 18829585
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 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
• Report Date (Section B): 07/10/2026

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: 09/10/2026
• Device Model Number: 106
• Device Lot Number: 7974
• 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: 06/16/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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: 64 YR
• Patient Sex: Male