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

Model Number MODEL 250

Device Problems Break (1069); Sticking (1597); Operating System Becomes Nonfunctional (2996)

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

Event Date 02/26/2015

Event Type  malfunction  

Event Description

It was reported that the handheld device had a frozen screen so a hard reset was performed.When the handheld powered back it, the handheld device was stuck on the screen alignment process.Another hard reset was performed but the issue continued.The handheld and software flashcard device have been returned to the manufacturer where analysis is currently underway.It was noted that the as-received handheld device had a damaged screen.

Manufacturer Narrative

Event Description

Product analysis was completed for the handheld device on 04/06/2015.The cause for the reported complaint is associated with a damaged touch screen display.Once the display was replaced, no further anomalies associated with the handheld performance were identified during the analysis.The cause of damaged touchscreen is due to mechanical stress and appears to be user related.Product analysis was completed for the software flashcard on 04/06/2015.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 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: 4623417
• MDR Text Key: 5592016
• Report Number: 1644487-2015-04201
• 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: 02/26/2015

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: Health Professional
• Device Model Number: MODEL 250
• Device Lot Number: 840143
• Other Device ID Number: VERSION 8.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 03/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1