MAUDE Adverse Event Report: CYBERONICS, INC. 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 10/13/2017

Event Type  malfunction  

Event Description

The company representative reported that the patient had been reporting adverse events with her m106 generator.The company representative had visited the patient a week prior to adjust the patient's settings per her physician's request and used his tablet with m3000 software.Upon interrogating the patient, he noted that the patient's magnet mode and autostimulation settings were programmed to the same value.He programmed the patient's magnet mode to a higher value.Shortly afterwards, the patient complained that she "felt the strongest stimulation" she had ever received.A week later.The patient had an appointment to adjust her settings.Her generator was interrogated and the following error message was observed "generator is off due to error." system diagnostics indicated that the output current was high.Another interrogation was performed and it was noted that normal mode, magnet mode and autostimulation mode output currents were at 0 ma.The day prior to the warning messages, the patient reported that she had stopped feeling stimulation and she believed that was when the generator turned off.The patient's settings were reprogrammed and the next diagnostics were within normal limits.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.In this case, the burst exceeded the expected on time and a burst watchdog timeout was triggered, leaving the generator in a pulse disabled state.The three conditions that are needed to trigger the above event are as follows: the autostimulation output current must be changed with a m3000 v.1.0 software tablet, but the magnet output current must be unchanged from a previous version m250 v.11.0 software programming event.Autostimulation and magnet output current must be >= 0.25 ma and frequency must be >= 10hz.An autostimulation burst must be interrupted by a magnet swipe.To resolve this issue, the patient's settings were reprogrammed to avoid this problem.No further relevant information has been received to date.

Manufacturer Narrative

Software version, corrected data: the initial mdr inadvertently omitted the software version: version 1.0.Device identifier, corrected data: the di for m3000 products was inadvertently omitted from the initial mdr.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS, INC.; 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: 7039579
• MDR Text Key: 92934481
• Report Number: 1644487-2017-04801
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

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: 10/20/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40 YR