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

Model Number	MODEL 3000
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was revealed during a periodic review of the manufacturer¿s programming history database that high impedance was observed on the patient¿s m102 vns generator.It was noted that the software was a m3000 (b)(4).The representative then programmed the output currents off and the diagnostics were within normal limits.This issue was duplicated with in-house testing.For model 102/102r generators programmed to output currents greater than 1.00 ma , it was observed that system diagnostics using m3000 (b)(4) and m250 software would display ok lead impedance while system diagnostics using m3000 (b)(4) software would display a false high impedance.It was determined that the cause of this false high impedance message was a software error on m3000 (b)(4) software; when system diagnostics were performed by the user with m3000 (b)(4) software on m102/102r generators (normal mode output current >0 ma), normal mode diagnostics would actually be performed instead.The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds.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: 9622594
• Report Number: 1644487-2020-00106
• Device Sequence Number: 16769255
• Product Code: LYJ
• UDI-Device Identifier: 05425025750429
• UDI-Public: 5425025750429
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2020

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: Other
• 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: 05/10/2019
• Initial Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR