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	05/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a low output current warning was observed on the patient's vns when increasing the settings from 0.625 ma to 0.750 ma.The lead impedance was within normal limits at 4,150 o and that the battery status was at 75-100%.The np indicated that she had been running both system and magnet mode diagnostics and that she had not waited for a full cycle to proceed.Cuq recommended system diagnostics be performed without a magnet swipe.Diagnostics were ran and found to be within normal limits.The vns was able to provide the programmed output current.No additional relevant information has been received to date.
Event or Problem Description
Review of the export data with qe revealed it was likely that the medical professional did not swipe the magnet upon performing magnet mode diagnostics.It was determined based off of the review that the false low output current likely appeared because the magnet settings were changed prior to performing the tests, such that the last delivered magnet pulse stored in the ipg did not match the new value as no magnet swipe had occurred yet.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8654054
• Report Number: 1644487-2019-01043
• Device Sequence Number: 13925599
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 05/07/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR