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

Model Number MODEL 250

Device Problem Failure to Advance (2524)

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

Event Date 11/12/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 a clinical technical support representative stated that the option to interrogate on the handheld screen was selected but the screen didn¿t advance.The representative tried to select user preferences and got no response.It was verified that the screen lock switch hadn¿t been set to the lock position.The device was powered off and back on with no success and then a hard reset was performed.He cleared all data from memory when prompted, tapped the screen to set up the pocket pc when prompted, and then tried to align the screen when prompted.The handheld didn¿t advanced beyond the align screen.Another hard reset was performed and it was able to proceed to the align screen prompt but couldn¿t get past it again.The edges of the screen were cleaned but that was unsuccessful.The device was again powered off, removed the flashcard and reinserted it, ensuring that it was fully seated, and powered it back on.Still, no success.The battery was removed and reinserted and it still didn¿t help.The handheld remained unable to advance past the align screen prompt.It was reported that the handheld had been tested on the evening of (b)(4) 2015 and morning of (b)(4) 2015 prior to the event and it had functioned perfectly.The handheld and flashcard were received for product analysis on (b)(4) 2015.Product analysis is still underway and has not yet been completed.

Event Description

Product analysis was completed on the handheld and flashcard on (b)(6) 2015.During the analysis on the handheld it was identified that the handheld was unable to advance past the screen alignment utility.The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry.No further anomalies associated with the handheld performance were identified during the analysis.No anomalies associated with flashcard software or databases were identified during the flashcard analysis; the flashcard and software performed according to functional specifications.

• 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: 5270973
• MDR Text Key: 33055398
• Report Number: 1644487-2015-06662
• 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: 11/12/2015

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: Other
• Device Model Number: MODEL 250
• Device Lot Number: 1588624
• Other Device ID Number: VERSION 9.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2012
• 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