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

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	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect device software version: version 1.0.2.4.
Event or Problem Description
It was reported that the patient's generator settings were changed to unintended settings by the programming system software.A review of the programming history found that the reported unintentional settings were programmed as part of a "standard protocol." this is consistent with information from the nurse practitioner, who indicated that during the initial interrogation the system showed guided programming, which is not a feature available on the model 106 generator the patient's implanted with.It was reported that the patient's settings were programmed as intended before leaving the dosing appointment.No other programming events were marked as standard protocol.No further relevant information has been received to date.
Additional Manufacturer Narrative
Describe event or problem, corrected data: the initial mdr inadvertently indicated that the guided programming was not an option on model 106 generators.
Event or Problem Description
Guided programming is an option for a model 106 device.It was determined that the guided programming feature of the m3000 software would naturally prompt a m106 generator programmed to the patient's intended settings to be programmed to the settings that the physician reported as unintended.The physician would have to decline the settings change to manually program to desired settings.In this case, the physician accepted the prompt which lead to the settings change.No device failure is expected.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING COMPUTER
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8242411
• Report Number: 1644487-2019-00060
• Device Sequence Number: 13984595
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2019

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: 12/17/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/14/2019
• Patient Sequence Number: 1
• Patient Age: 17 YR