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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2014

Event Type  malfunction  

Manufacturer Narrative

Event Description

During review of programming and diagnostic history, it was observed that the vns patient's device was programmed to settings on (b)(6) 2014 which were indicative of an interrupted system diagnostic test.The last programming data showed that the device was last programmed at the end of an office visit on (b)(6) 2014.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received indicating that the physician's office has multiple programming systems.It was also indicated that a comprehensive retrieval of programming history was performed on their systems in (b)(6) 2015, indicating that the interrupted system diagnostic responsible for the change of settings would be represented in the available programming history.As the final system diagnostic present before the change of settings was followed by a normal mode diagnostic with the appropriate output current, the change of settings did not occur at this time.No additional pertinent 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: 5300247
• MDR Text Key: 34326073
• Report Number: 1644487-2015-06700
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• 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: N
• Patient Sequence Number: 1
• Patient Age: 47 YR