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

Model Number MODEL 250

Device Problem Failure to Charge (1085)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

It was reported that the tablet device would not hold a charge and was sometimes unresponsive to the stylus.The tablet device has been returned to the manufacturer where analysis is currently underway.

Event Description

Product analysis was completed for the tablet device on 04/28/2015.No anomalies associated with the main battery were noted during testing using the ac adapter or the main battery with a full charge.During the analysis it was identified that the tablet would not respond to taps made by the digitizer pen.The cause for the anomaly is associated with a depleted battery.Once the battery was replaced, no further anomalies were identified.The depleted battery in the stylus pen was the likely cause of the event.

• 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: 4651911
• MDR Text Key: 5759509
• Report Number: 1644487-2015-04349
• 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: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• 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: 03/27/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1