MAUDE Adverse Event Report: HOUSTON GENERATOR MODEL 106; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number	1000-D
Medical Device Problem Codes	Premature Discharge of Battery (1057); Electrostatic Discharge (2149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error code 14 was seen upon interrogation, the generator was in a "disabled" status.The associated error code read: "the generator is currently disabled due to error code 14.The generator is not supplying stimulation." the patient has reportedly not perceived stimulation.Diagnostics are within normal limits.The patient's settings were reduced from 3.25 ma -->.75 ma (normal mode) & 3.5 ma ---> 1 ma (magnet mode).After this output reduction, the output current was able to be delivered.A battery life calculation was performed indicating that the device had depleted faster than expected.A review of the generator's data was conducted, revealing confirmation of the error code 14 issue.Based on an internal review of the details of the event, it was reported that the cause of the event was likely related to electrocautery.Later, as anticipated, a report of premature end of life was alleged.It was reported that the battery was at was at 75-100% battery life on (b)(6) 2025 but was seen at 8-15% battery life on (b)(6) 2026.The surgeon claimed that electrocautery was not used during the initial implant procedure.Updated tablet data was not provided; no further investigation can be conducted as a result.
Event or Problem Description
Later, an updated was received indicating that the generator was replaced prophylactically.It was reported that the explanted generator was discarded and is unavailable for return.No corrective action is needed as there is no new harm or risk established for the patient or user.

• Brand Name: GENERATOR MODEL 106
• Common Device Name: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): HOUSTON; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 24932922
• Report Number: 1644487-2026-10477
• Device Sequence Number: 17438359
• Product Code: LYJ
• UDI-Device Identifier: 05425025750528
• UDI-Public: 05425025750528
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/15/2026

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: 01/05/2025
• Device Model Number: 1000-D
• Device Lot Number: 7472
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female