MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number	MODEL 3000
Medical Device Problem Codes	Energy Output To Patient Tissue Incorrect (1209); Improper Device Output (2953)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Software version 1.0.
Event or Problem 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
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 7133752
• Report Number: 1644487-2017-05024
• Device Sequence Number: 1327894
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR