MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE

Model Number	MODEL 3000
Medical Device Problem Codes	Failure to Deliver Energy (1211); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a generator had disabled output error seen during a patient's initial implant surgery.Representative had issues with the wand batteries during the surgery and suspected this may have caused the issue.Representative changed the batteries and re-interrogated the device three successful times without the "output current: disabled" message appearing.After review of the situation and the three successful interrogations and system diagnostics within normal limits the surgeon continued and concluded the procedure.Internal data from the generator was reviewed.The created decoder shows the generator was interrogated in a stim stopped state.Tablet software version was found to be v1.6.1.9.Communication logs were reviewed.A different generator was interrogated prior to the new one.The first generator was in day/night mode.Without power cycling the tablet, the second generator was interrogated.The root cause of the generator disablement was due to a known software issue on version 1.6.1 that was identified following a specific sequence of events.For this event to occur, a model 1000 device must be interrogated with an affected model 3000 device, then day-night mode is enabled on that model 1000 generator and the session is ended with out powering off the tablet.Next a second model 1000 device is interrogated using the same model 3000 programmer and has guided mode enabled.Step-up or step-down program operation is attempted which places the generator in stop state.The user will be presented with a programming error and programming will fail and force the user to re-interrogate.If re-interrogation is unsuccessful, the generator will be left in stop-stim (disablement) run state.This known defect has been resolved in the release of software v1.6.2.No other relevant information has been received to date.
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.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15262694
• Report Number: 1644487-2022-01026
• Device Sequence Number: 5634072
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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: MODEL 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2018
• 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: 19 YR
• Patient Sex: Female