MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Image Resolution Poor (1306); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the physician's tablet was not functioning properly.It was observed that half of pixels on the tablet screen were not functioning.The physician was provided with a new tablet.The suspect tablet was received and is pending product analysis.

Event Description

Product analysis was performed on the tablet where it was noted that half of the tablet display was distorted.During analysis the display was replaced with a known functioning display.The tablet was then powered on and the vns software booted normally.A virus scan was performed and no anomalies were observed.The tablet performed to functional specification after the tablet display was replaced.It was determined that the cause for the distorted portion of the tablet was associated with a defective display.

• Brand Name: PROGRAMMING COMPUTER
• 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: 6180414
• MDR Text Key: 62922085
• Report Number: 1644487-2016-02888
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1