MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE

Model Number	3000-V1.6
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or "malfunctions".These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
Event or Problem Description
It was reported that the patient's generator was showing error code 10: device disabled, and that while interrogating the device, the patient's generator showed up as the incorrect model and serial number, as well as a software incompatibility malfunction appearing.It was further reported that the patient was hospitalized due to increased seizure episodes and experiencing new seizure types.It is believed this is due to a vns malfunction.The physician confirmed that no trauma or anything out of the ordinary occurred that could¿ve caused the device to malfunction.A generator reset was attempted, although unsuccessful, as the same error message of software malfunction was seen.The generator reset malfunction, increased seizures and new seizure type are reported on in mfr.Report # 1644487-2025-00243.
Event or Problem Description
It was further reported that the patient had undergone a battery replacement due to the generator incompatibility message which read "incompatible generator - this software is not compatible with this model of generator (error code 125)." the generator replacement is reported on in mfr.Report # 1644487-2025-00243.
Event or Problem Description
Product analysis was completed on the returned generator related to report 1644487-2025-00243.Analysis of the device revealed that the generator firmware was corrupted which caused the generator to reboot in a looped state.During these reboots, the device was not supplying stimulation which caused the increased seizures and change in seizure pattern.The looping of the reboots contributed to the issues observed on the programming tablet.The generator reboot, increased seizures and change in seizure pattern is captured in report 1644487-2025-00243.No other relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; 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: 21542833
• Report Number: 1644487-2025-00244
• Device Sequence Number: 7735754
• Product Code: LYJ
• UDI-Device Identifier: 05425025750535
• UDI-Public: 05425025750535
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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: Health Professional
• Device Model Number: 3000-V1.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2025
• Supplement Date Received by Manufacturer: 03/07/2025; 02/19/2026
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/01/2025; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 45 YR
• Patient Sex: Male