MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE

Model Number	MODEL 3000
Medical Device Problem Code	Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect device software version: version 1.0.
Event or Problem Description
It was reported that the patient's vns generator was programmed on after the vns implant surgery using a new vns programming tablet with m3000, version 1.0, software.However, at the follow up visit with the patient's physician a few weeks later, interrogation with a m250, version 11, software tablet revealed that the settings had been changed.The company representative indicated that the hospital did not have a vns programmer, so it was unlikely that the vns had been reprogrammed.Review of the m3000 programming data indicates the device was programmed in such a way to be susceptible to burst watchdog timeouts following a magnet swipe.Review of the physician's tablet data confirms the burst watchdog timeout was found at the follow-up appointment and had a single completed magnet stimulation logged.This is likely the event that resulted in the burst watchdog timeout.No additional relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 7043182
• Report Number: 1644487-2017-04817
• Device Sequence Number: 1411158
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 11/09/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR