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	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Software version: (b)(4).
Event or Problem Description
It was reported that high impedance was observed pre-operatively with (b)(4) software prior to a generator replacement due to low battery.For model 102/102r generators programmed to output currents > 1 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.The physician assessed that the cause of the high impedance was likely related to the software and that the treatment decision was not effected, as the patient was previously referred for generator replacement and the leads remained intact.It was reported that there was no known trauma or manipulation.The explant facility does not return explanted products, therefore, return of the generator is not expected to date.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: 8912214
• Report Number: 1644487-2019-01612
• Device Sequence Number: 11167266
• Product Code: LYJ
• UDI-Device Identifier: 05425025750429
• UDI-Public: 05425025750429
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR