MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure of Device to Self-Test (2937)

Patient Problems Dyspnea (1816); Pain (1994)

Event Date 10/22/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient's device was tested recently and the patient began coughing and gagging due to device stimulation delivered from the diagnostic test.The patient's device had previously been disabled and believed to have remained programmed off following the office visit.Additional information was received stating that the patient's device was evaluated by another physician on (b)(6) 2015 as the patient had been experiencing left jaw pain and the device was found to be programmed on.It is possible that an interrupted system diagnostic test occurred during the previous office visit that caused an unintended change in device settings.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional programming and diagnostic history was received which showed that an interrupted system diagnostic test occurred at the end of the office visit on (b)(6) 2015 which likely caused the unintentional device enablement.A final interrogation was not performed.An interrogation prior to the interrupted test confirmed that the device was disabled.

• 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: 5294773
• MDR Text Key: 34005779
• Report Number: 1644487-2015-06734
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

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
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Device Lot Number: 1063824
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR