MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

It was reported that when attempting to interrogate the vns patient¿s device, the handheld device showed an error message stating ¿self-test failed on this program.¿ hard resets were performed and the software flashcard was reseated; however, the issues did not resolve.The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.

Event Description

Product analysis was completed for the handheld device on (b)(6) 2015.No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.The handheld performed according to functional specifications.Product analysis was completed for the software flashcard on (b)(6) 2015.The handheld was received with the main battery depleted.As a result, the handheld memory where the executable is stored was cleared.An analysis was performed on the returned flashcard and no anomalies associated with flashcard software were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4648285
• MDR Text Key: 5756598
• Report Number: 1644487-2015-04308
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• 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: 1075850
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR