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	05/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the neurologist interrogated a patient's device and the patient's output currents were disabled for normal mode, magnet mode and autostimulation.No other relevant information has been received to date.
Event or Problem Description
The neurologist provided patient information.Internal investigation identified that the software will provide an invalid parameter values warning and set all output currents to zero if specific criteria are met, which include: a m106 ipg with at least one of magnet and/or autostim output current programmed to 3.5ma and normal mode output current programmed to less than 3.5ma.Autostim is enabled frequency and the other currents meet the following criteria: frequency - 25hz / normal mode output current - 3.25ma / autostim or magnet current is at least - 3.25ma.A frequency change has not occurred since the last time the 3.5ma current(s) was programmed.
Additional Manufacturer Narrative
Model #, corrected data: initial report inadvertently listed incorrect format for model #.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 7650983
• Report Number: 1644487-2018-01102
• Device Sequence Number: 2435284
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/12/2019

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: 06/13/2018
• Supplement Date Received by Manufacturer: 07/31/2018; 06/12/2019
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/21/2018; 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR