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

Model Number	MODEL 3000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Software version 1.0.2.4.
Event or Problem Description
It was reported that after a systems diagnostics test on the m3000 tablet, the patient¿s settings were changed, indicative of a faulted diagnostics test or a programming anomaly.It was then stated by the company representative that they ended the generator session, re-interrogated the device, and set the generator to the desired settings.However, after this, the patient was reinterrogated and the settings were not changed as desired.Therefore, an older version (m250) tablet was used to program the device, instead.A review of the data from the m3000 tablet verified that there was a faulted diagnostics test during the visit.However, the change in settings indicative of a faulted diagnostics tests, appeared to have occurred after an interrogation and not after a diagnostics or programming event as expected.There was a programming event after the device was found at the anomalous settings; however, it appeared to not try to change any settings.No further relevant information has been received to date.
Event or Problem Description
It was determined through a review of the tablet's log files that the cause of the change in settings was be due the faulted/interrupted diagnostics test.The reason that the settings indicative of a faulted diagnostics test did not appear immediately after the faulted test in the manufacturer's programming database (and instead was listed after a programming and interrogation event) was due to the way due to the way the model 3000 tablet documented events to the csv file used to make the database.Per the log files, the programming event just after the diagnostics tests was only changing the patient's implant date/id.The csv file for a programming event will only update changed parameters, where all others will be pulled from most recent successful interrogation.As such, the programming database shows the prior settings before the faulted test.Directly after this programming event, the interrogation event indicated that the settings were ok because communication failed during the event.When the interrogation failed, the tablet still recorded an interrogation attempt, but auto-pulled data from the most recent successful interrogation.The second interrogation did complete successfully, and the true settings that occurred due to the faulted diagnostics test were recorded properly.Therefore, this change in settings is a known potential consequence of interrupted diagnostics test, and is not unexpected.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: 7927581
• Report Number: 1644487-2018-01740
• Device Sequence Number: 16609139
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR