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

Model Number 3000

Device Problems Computer Software Problem (1112); Energy Output Problem (1431)

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

Event Date 05/23/2018

Event Type  malfunction  

Event Description

The patient reported that at her last appointment her generator was reset to "factory settings".She was able to be programmed back to her original setting but was in the end programmed to lower settings due to discomfort at her original settings.She had not noticed anything unusual in her stimulation pattern prior to this report.No further relevant information has been received to date.

Event Description

A session report from the patient's previous appointment showed that the final settings were as expected no further relevant information has been received to date.

Event Description

New programming data for the patient's generator was reviewed.It was determined that at the appointment prior to the detection of unintended settings, a faulted/interrupted diagnostics test occurred.A final interrogation did not occur after this to confirm settings.Based on this, it can be concluded that the cause of the unintended settings was the interrupted diagnostics at the previous appointment.Due to how diagnostics are performed on model 102r generators, which changes the settings to run the test, interrupted diagnostics may lead to unintended settings changes.It should be noted that labeling indicates that final interrogations should be performed at the end of every appointment to confirm correct settings.No further relevant information has been received to date.

• 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: 8185614
• MDR Text Key: 131154576
• Report Number: 1644487-2018-02360
• Device Sequence Number: 1
• Product Code: LYJ
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3000
• Device Lot Number: 202951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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: 38 YR