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 Problem Neck Pain (2433)

Event Date 11/10/2017

Event Type  malfunction  

Event Description

It was reported that this patient was programmed to 0.25ma using the m3000 software.When system diagnostics were run with the m3000 software, they were run at 1.0ma which caused the patient pain in the neck area.The patient was re-interrogated and found to still be at 0.25ma and diagnostics were run again, and this time, were correctly run at 0.25ma with the m3000 software.Next the patient was programmed to 0.375ma and diagnostics were run using m250 software, which were performed correctly at 0.375ma.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.

Manufacturer Narrative

Software version 1.0.Serial #, corrected data: initial report inadvertently did not list a serial number.Unique identifier #, corrected data: initial report inadvertently did not list a di number.

Event Description

During a database review, it was observed that during the initial interrogation the generator was found to be in a pulse disabled state due to burst watchdog timeout (bwt).The combination of normal mode and magnet mode output current for this generator resulted in an excessive magnet ramp time that would result in bwt after a magnet stimulation.After the first interrogation, diagnostics were attempted but were faulted and logs show that no data was received back from the generator.However, as this occurred prior to therapy being programmed back on, the attempted diagnostic would have used a 1ma burst by design.After the output current was programmed back on and set to a specific output current, an additional diagnostic test was performed, and the achieved output current was as expected.No other relevant information has been received to date.

• 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: 7088895
• MDR Text Key: 94505190
• Report Number: 1644487-2017-04945
• 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: 01/19/2018

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: 11/10/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/19/2018
• 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: 33 YR