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

Model Number MODEL 250

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591)

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

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a nurse was having an issue with the programming tablet on (b)(6) 2016.The tablet was described as " frozen" and pressing the force quit button as well as a restart button did not resolve the issue.The tablet was reported to be at the menu screen and the nurse only had an option to look at the database as all other buttons were greyed out.The nurse also reported that the tablet dims and brightens on its own and it did not respond to touch or tap gestures.The tablet also presented a windows error message.The nurse attempted to tap on ok button but the tablet was unresponsive.The tablet was restarted but this did not resolve the issue.The error message was present after a few minutes of normal use.The sd card is confirmed to be present.The tablet was not dropped per the nurse.Additional information was received that the tablet was turned off and charged over the weekend, and that when a field representative examined the tablet after the weekend, no errors were encountered.The field representative was able to interrogate a demo generator without issue and did not see any errors.The tablet is expected to be returned but has not been received.

Event Description

The suspect tablet was received on (b)(6) 2016.No anomalies associated with the tablet software were noted during testing using the ac adapter or the main battery with a full charge.During the analysis, it was identified that the touchscreen was unresponsive and the tablet would display an application error message.The cause for the anomaly is associated with an unlocked cable connector on the main pcb.The cable connector connects the tablet touchscreen to the motherboard.Once the connector was moved to the locked position, 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: 5499225
• MDR Text Key: 40562638
• Report Number: 1644487-2016-00548
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

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: MODEL 250
• Other Device ID Number: VERSION 11.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• 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