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	10/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at a dosing appointment for a patient with a m102, the duty cycle was found to be at 1% upon advanced interrogation with m3000 v1.0 software.The session report showed that the initial and final interrogation settings were as expected.The patient's settings were corrected during the same visit.No further relevant information has been received to date.
Event or Problem Description
The generator's programming history was reviewed.There was no evidence of a change in duty cycle nor a faulted diagnostics during the reported event.Review of the internal tablet data indicated no obvious warning message regarding the duty cycle reported.It was determined that although the report indicated that the observed duty cycle happened after interrogation, it was likely that it occurred after system diagnostics due to the absence of any data showing a 1% duty cycle.Instead, there is a know display error that would explain why a 1% would show after system diagnostics.Any time system diagnostics is performed in-session and the user navigates back to the parameters screen, all values will display correctly (including on time and off time), except for the calculated duty cycle, which will show 1%.This display occurs because the system diagnostics will program the generator to this duty cycle to run diagnostics prior to programming them back to the intended cycle.In these cases the generator is operating at intended duty cycles settings and reinterrogation will resolve the display error.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: 8010781
• Report Number: 1644487-2018-01936
• Device Sequence Number: 1552668
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 02/06/2019

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: MODEL 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR