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

Model Number MODEL 250

Device Problems Loss of Power (1475); Failure to Power Up (1476); Delayed Charge Time (2586); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2015

Event Type  malfunction  

Event Description

It was reported that the programming tablet has been charging for a long time and the battery light is still flashing amber.The tablet was unplugged and immediately powered off and would not power back on.The tablet was plugged back into the power cord and the battery light illuminated red and then flashed amber again.It was reported that the tablet was last used on (b)(6) 2014 and that it had been plugged into a power source for a long time.After 10 minutes the tablet was again removed from the power source and immediately powered off and would not power back on.The site was provided a new programming tablet and the non-functional tablet was received for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Event Description

Product analysis was completed for the tablet device.A visual analysis inside the tablet case identified a loose cable that connects the main battery to the motherboard.This condition can cause an intermittent electrical connection that can prevent the tablet from operating on battery power and charging the main battery.With the tablet in its ¿as received¿ condition no anomalies associated with the tablet performance were noted during testing.The tablet performed according to functional specifications.

Manufacturer Narrative

The loose cable was identified as a possible cause for the battery not holding its charge, but the failure could not be confirmed.

• 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: 4542038
• MDR Text Key: 5514888
• Report Number: 1644487-2015-03968
• 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: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• 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 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1