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

Model Number MODEL 250

Device Problem Failure to Charge (1085)

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

Event Date 10/03/2016

Event Type  malfunction  

Event Description

Information was received indicating that the physician's tablet was not able to hold a charge.Multiple wall outlets were attempted.The power adaptor was exchanged and the problem still persisted.When troubleshooting was performed, the device was unable to even power on.The tablet has not been received to date.

Event Description

The physician's tablet was received on 11/08/2016 and underwent product analysis which was completed on 11/29/2016.The product analysis found no anomalies with the physician's device.The tablet's main battery was able to be fully recharged successfully using the power supply adapter.The tablet subsequently was able to perform interrogations and programming.After testing the battery was at 82%.No device failure was found.

• Brand Name: PROGRAMMING SOFTWARE
• 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: 6061655
• MDR Text Key: 58664391
• Report Number: 1644487-2016-02477
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

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
• Other Device ID Number: VERSION 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1