MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Image Display Error/Artifact (1304); Device Displays Incorrect Message (2591)

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

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that a nurse turned on her tablet and received a message stating "the database is incompatible." the programmer has been functioning fine in the past.The message first appeared on (b)(6) 2016.A forced reboot was performed by the sales representative and after it was powered back on the same message appeared.The "ok" button on the screen was selected and the display went to a blank white screen.Another reboot was attempted but the same message appeared.Additional troubleshooting was performed by removing the sd card, rebooting the tablet, and attempting to interrogate again but this was also unsuccessful.The tablet was received for analysis on 04/29/2016.Analysis is underway but has not been completed to date.

Event Description

Product analysis for the tablet was completed and approved on 05/17/2016.An analysis was performed on the returned tablet and no anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.The tablet performed according to functional specifications.During the analysis it was identified that the vns software would display an error message indicating that the patient database was incompatible with the vns software.An analysis of the database identified that it was corrupt.The vns software was displaying the compatibility error as a result of the file corruption.Once the file was replaced with a known good database, no further anomalies were identified.

• 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: 5644290
• MDR Text Key: 46212557
• Report Number: 1644487-2016-00987
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• 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 11.0.4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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