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

Model Number MODEL 250

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

Analysis of the returned handheld device and software flashcard was completed.During analysis, it was identified that the handheld was unable to advance past the welcome screen.The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry.Once the display was replaced with a known good display, 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.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

Event Description

It was reported that the neurologist was unable to pass the alignment screen on her handheld device.Multiple hard resets were performed, the screen was cleaned, and the lock button was confirmed to be not engaged.However, the issue did not resolve.The handheld device was returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4037865
• MDR Text Key: 4785960
• Report Number: 1644487-2014-02105
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/31/2014

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
• Device Lot Number: 1063830
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 08/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1