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

Model Number	3000
Medical Device Problem Codes	Computer Software Problem (1112); Energy Output Problem (1431); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's output currents were increased for both day and night mode.Diagnostics were performed immediately afterward and an "output current not delivered" message was received.Lead impedance and battery status were within normal limits.Per ohm's law calculation the generator should be able to deliver the programmed output current.Tablet data was reviewed.The peak output current delivered equivalent to the value for daytime settings, but was lower than the programmed nighttime settings.The diagnostics were performed 2 minutes after the settings change, which would be during the period of time in which the generator was running nighttime settings.There were no noted reboots or therapy status flags.Generator device history record was reviewed; no unresolved non-conformances were identified, and the generator passed all quality control specifications prior to distribution.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9683936
• Report Number: 1644487-2020-00164
• Device Sequence Number: 16844093
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/07/2020

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: 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR