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

Model Number	MODEL 3000
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor interrogated this patient's device and the impedance came back normal however the current delivered came back low.When the patient's device was interrogated later, the impedance came back as normal, and the output current was also stated to be within normal limits.Internal programming history was reviewed which revealed that the patient¿s output current settings (normal, magnet and autostim) were increased at the office visit.After the settings were increased a system diagnostic, autostim diagnostic and magnet mode diagnostic were performed in succession.The low output current warning was seen after magnet mode diagnostics were performed, where a magnet must be swiped for the test to perform as intended.It was confirmed through a system diagnostic test that the appropriate output current is being delivered.This event has been determined to be due to software error in the m3000 programmer that causes the summary screen to be updated even if an incomplete magnet mode diagnostic test is performed (no magnet swipe prior to performing magnet mode diagnostics).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: 8226520
• Report Number: 1644487-2019-00031
• Device Sequence Number: 16208933
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/08/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR