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

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)

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

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that the tablet received an "odd bootup error" just a few minutes prior, but eventually it loaded the software successfully.It was stated that it got stuck on the vns logo and required a forced restart.This issue happened twice before it started working again normally.Then during an attempt to download the patient's data it kept saying to "please insert a valid sd card", but then eventually it worked.It was confirmed that the sd card was ordered from livanova.All this happened within a 4 hour period.The issues persisted.The tablet had the attached error message at boot up and needed to be powered off by holding down the power button to reboot it.Upon reboot it would not interrogate his demo generator.It also hangs nearly every time it is powered off and the power button has to be held to get it to power off.The tablet was returned on 04/20/2016 and analysis is underway but has not been completed to date.

Event Description

Product analysis for the tablet was completed and approved on 05/09/2016.An analysis was performed on the returned tablet and during the analysis, it was identified that the tablet was unable to access the sd card.The cause for the anomaly is associated with a cracked solder connection between the main board and the card detect lead of the sd memory card socket.Although the sc card socket was disabled, the vns software still had limited functionality and was able to interrogate, program, and perform diagnostic tests during the analysis.Once the lead was soldered onto the main board, no further anomalies were identified.

• 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: 5637395
• MDR Text Key: 46086336
• Report Number: 1644487-2016-00973
• 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: 04/12/2016

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: Other
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2015
• 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