MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number MODEL 3000

Device Problems Energy Output To Patient Tissue Incorrect (1209); Improper Device Output (2953)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Software version 1.0.

Event Description

It was reported that the patient was experiencing painful stimulation that occurred when the magnet was swiped.The patient only started experiencing this pain since the most recent adjustment, made with the m3000 programmer.The patient was told to stop using the magnet, until their settings could be adjusted by the doctor.The patient was seen 3 weeks later to reprogram their generator using an older programming system.The magnet current was reduced to help with tolerability.System diagnostics were run and were within normal limits.The patient felt much better about the settings after this appointment.These events have been determined to be due to software error in the m3000 programmer that causes certain parameters to be incorrectly calculated in m106 generators.These incorrect calculations along with a combination of programmed settings, magnet swipes, and autostimulation may lead to a period of continuous current ramping for part or all of an entire therapy burst.During this ramping, the current can exceed programmed values.This is likely the cause of the patient's reported painful stimulation.To resolve this issue, the patient's settings were reprogrammed to avoid this problem.No further relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7133752
• MDR Text Key: 95476439
• Report Number: 1644487-2017-05024
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• 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
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR