MAUDE Adverse Event Report: HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number	106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Nausea (1970); Balance Problems (4401); Syncope/Fainting (4411); Speech Disorder (4415); Heart Block (4444); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that it is suspected that the vns caused high grade av block and bradycardia to 24 bpm for the patient.On (b)(6) 2025, the patient experienced episodes of going pale, slurring speech, feeling sick and unsteady on feet.This caused the patient to sleep for several hours afterwards.Further details received noting that the patient also experienced syncope but there were no noted traumatic events or triggers prior to the arrhythmia.The event did not occur following a medication change, it did not correlate with the on time and did not occur while performing a diagnostic or following a settings change.An ecg was performed to diagnose the arrhythmia and it was assessed as being related to vns therapy stimulation.The patient's device was disabled on (b)(6) 2025 and there was no further av block or bradycardia seen on the holter and zio patch results.No other relevant information has been received to date.

• Brand Name: PULSE GEN 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; 2816672681
• MDR Report Key: 25612913
• Report Number: 1644487-2026-10762
• Device Sequence Number: 18690716
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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 Model Number: 106
• Device Lot Number: 973
• 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: 06/01/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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: Hospitalization; Life Threatening
• Patient Age: 14 YR
• Patient Sex: Unknown