MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE

Model Number	3000
Medical Device Problem Codes	False Alarm (1013); Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Software version - (b)(4).
Event or Problem Description
It was reported by a nurse that when the nurse programmed a patient back on after it had been disabled for an mri, a low output current pop-up message was received on her v1.6 tablet.It said to lower the current and increase the pulse width.So, the nurse did that and then went to interrogate in the same session but the same message popped up.After exiting and starting a new programming session on a new programmer with the patient , the low output current message went away.The data was reviewed and it was observed that the patient's generator was programmed off.Then several hours later a new session was started and the patient's vns was programmed back on and no diagnostics were run.Internal testing and data review identified that false low output current messages can occur when m3000 v1.6 software programs a m103-106 generator after a specific programming sequence occurs.When m3000 v1.6 tablets initiate a programming session with a m103-106 generator, where its output current is programmed off (0 ma), and then the output current is programmed back on to >0 ma, a low output current message would be seen when an in-session interrogation is performed.This would persist upon multiple in-session interrogations and if diagnostics weren't performed during the session, show on the session report.Running system diagnostics or ending and restarting the session will confirm functionality of the device, and resolve the output current low error message.The low output current messages in these cases are false and do not impact generator function.Based on the report from the nurse and data review, the programming sequence that occurred that day was consistent with the false low output current mechanism described above no further 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
• MDR Report Key: 11348921
• Report Number: 1644487-2021-00225
• Device Sequence Number: 2563992
• Product Code: LYJ
• UDI-Device Identifier: 05425025750443
• UDI-Public: 05425025750443
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR