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

Model Number	MODEL 3000
Medical Device Problem Codes	Computer Software Problem (1112); Energy Output Problem (1431)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an invalid parameters warning message was observed on a m3000 tablet v1.0 software when a patient was interrogated at her appointment.After the message, the device's autostimulation output current was found to be turned off and the magnet stimulation was also disabled.Another tablet was then used to program the patient back to the correct settings and that there were no further similar issues at the appointment.A review of the internal data and programming history determined that there was no evidence of intentional disablement nor was there a known reason for the unexpected disablement based on device settings.No further relevant information has been received to date.
Event or Problem Description
Through review of the internal data of the tablet, the report of the invalid parameters warning message on 1.0.2.4 software.Through a review of the generator's office visit data, it was found that the patient's generator had last been programmed approximately a month prior to the invalid parameters message by a tablet with unknown software version.If the patient was programmed by a 1.0.1.7 software version during the visit prior to the visit where the invalid parameters message was seen, it may have triggered the invalid parameters message.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: 8185155
• Report Number: 1644487-2018-02359
• Device Sequence Number: 1458859
• 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): 01/31/2019

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: 11/27/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/31/2019
• Patient Sequence Number: 1
• Patient Age: 53 YR