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

Model Number	3000-V1.6
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported that she was trying to interrogate the patient in clinic and was receiving lots of error messages, and when she was finally able to interrogate she increased output current from 0.75 ma to 1ma.Diagnostics were normal.She then exited the session and tried to re-interrogate but again received error messages.She switched tablets and was able to interrogate, however it showed the low output current symbol and noted only 0.75ma being delivered.Impedance was ok, 2702 ohms.The device was shown to be programmed to 1ma.She tried running diagnostics but the patient started to cough so she ended the diagnostics.She noted that it was no longer showing low output current and all following tests were normal.Review of the data revealed that the event was likely related to a partial programming event.If the partial programming event had changed output current, but the generator did not receive the startstim command before the programming event failed (telling it to start stimulation), a low output current message can be received if the user chooses to not retry the programming event and interrogates again before the off time expires.This is because the software is comparing the new programmed current value to measured delivered peak current and the pulse generator has not yet delivered the new current (which would update peak current to the new programmed current).No other 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: 10637681
• Report Number: 1644487-2020-01338
• Device Sequence Number: 1179067
• Product Code: LYJ
• UDI-Device Identifier: 05425025750535
• UDI-Public: 05425025750535
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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-V1.6
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR