MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Operating System Version or Upgrade Problem (2997)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that a technician upgraded a cl 910 tablet with v11.0.5 software and now the tablet is nonfunctional.The upgrade to v11.0.5 software is only for cl900 tablet therefore it is expected that the software would not function properly.Notification was sent to the upgrade team to reinforce that the upgrade is only for cl900 tablets and they should not attempt to upgrade a cl910 tablet.Follow-up with the project leader revealed that additional training and instructions will be provided to technicians in the event the upgrade is performed on the incorrect tablet model.The tablet was received for product analysis on 10/09/2015.Product analysis is still underway and has not yet been completed.

Event Description

Product analysis was completed on the tablet on (b)(4) 2015.During the analysis it was identified that the tablet would not advance past the cyberonics splash screen.The cause for the anomaly is associated with the incorrect operating system being installed into the tablet.The installer installed an operating system intended for a cl900 tablet into a cl910 tablet.Once the correct operating system was installed, 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: 5183957
• MDR Text Key: 30268247
• Report Number: 1644487-2015-06256
• 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: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1