MAUDE Adverse Event Report: LIVANOVA USA, INC. PROGRAMMING SOFTWARE

Model Number	3000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a physician turned off a patient's generator before an mri and when he turned it back on, the programmed current was not being delivered.This is consistent with a false "low output current" message seen in (b)(4) software.However, the software version was not confirmed.It was reported that the message was seen multiple times.As this message can occur repeatedly until the session is exited, it is unclear if this happened multiple times on the same patient or for another patient.A report for the event that this is in reference to another patient will be submitted under manufacturing report #1644487-2020-00019.Internal testing and data review identified that false low output current messages can occur when m3000 (b)(4) software programs a m103-106 generator after a specific programming sequence occurs.When m3000 (b)(4) 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.No further relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9548404
• Report Number: 1644487-2020-00009
• Device Sequence Number: 19411837
• Product Code: LYJ
• UDI-Device Identifier: 05425025750443
• UDI-Public: 05425025750443
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

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: 12/10/2019
• Initial Report FDA Received Date: 01/03/2020
• Patient Sequence Number: 1