MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problem Operating System Version or Upgrade Problem (2997)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2015

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2015 from an upgrade specialist that he was about to start the upgrade process for this tablet, but the database utilities button was grayed out.This issue was discovered on (b)(6) 2015.He indicated that he tried rebooting about 5-6 times and even used 3 different sd cards but the button would not work.The tablet that was having issues is expected to be returned for analysis but has not been received to date.

Event Description

The tablet was received for analysis on 10/12/2015.Product analysis for the tablet was completed and approved on 11/04/2015: an analysis was performed on the returned tablet and during the analysis it was identified that the tablet was unable to recognize the sd card.As a result, the database utilities button was disabled in the vns software.The cause for the anomaly is associated with a hardware failure on the main board.The anomaly will prevent the ability to perform a software upgrade.Although the database utilities button was disabled, the vns software still had limited functionality and was able to interrogate, program, and perform diagnostic tests during the analysis.

Event Description

An addendum to product analysis of the tablet was completed and approved on (b)(6) 2016: visual inspection of the sd memory card slot leads identified no anomalies.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 5135916
• MDR Text Key: 28181492
• Report Number: 1644487-2015-06053
• 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: Other
• Type of Report: Followup,Followup
• Report Date: 09/14/2015

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
• Other Device ID Number: VERSION 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/05/2015; 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2014
• 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