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

Model Number MODEL 3000

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2018

Event Type  malfunction  

Event Description

It was reported that the physician ran diagnostics on the patient's vns and it was stated that it looked like there were lead issues.High impedance was observed on the patient's m102 vns generator when using the physician's m3000 v1.5.2.1 vns programming system with a dcdc code of 4.However, diagnostics with a motion vns programming tablet revealed that the high impedance reading was false.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 v1.0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1.5 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 v1.5.2.1 software; when system diagnostics were performed by the user with m3000 v1.5.2.1 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 additional relevant information has been received to date.

Event Description

The physician's vns tablet diagexport log was reviewed and the diagnostic performed was confirmed as a systems diagnostics test.

Manufacturer Narrative

Corrected data: initial report inadvertently listed "m3000-v1.5" instead of "model 3000".Unique identified #, corrected data: initial report inadvertently listed "(b)(4)" instead of "(b)(4)".

Manufacturer Narrative

Unique identifier #, corrected data: follow-up report #2 inadvertently listed "(b)(4)" instead of "(b)(4)".

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8262486
• MDR Text Key: 133854429
• Report Number: 1644487-2019-00102
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750429
• UDI-Public: 05425025750429
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR