MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number 250-11.0.5

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Computer Operating System Problem (2898)

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

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the physician's tablet was not booting up properly.When loading, it was noted the tablet would get to the screen with the windows logo with the moving dots, but then it would lock up.A hard re-boot was attempted, but the tablet would still not boot up properly.The tablet was received by the manufacturer; however, analysis has not been completed to date.

Event Description

Product analysis was completed for the returned tablet and software.During analysis of the tablet, it was identified that the tablet would freeze while the windows operating system was booting up.The cause for the anomaly is associated with a defective main board.Once the board was replaced, no further anomalies associated with the tablet performance were identified.No software anomalies were identified during analysis.

• 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: 5479897
• MDR Text Key: 39943254
• Report Number: 1644487-2016-00465
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

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: 250-11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• 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