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

Model Number MODEL 250

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Application Program Problem (2880)

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

Event Date 10/16/2015

Event Type  malfunction  

Event Description

It was reported by the physician that the tablet "freezes up".However, the company representative's demo generator was able to be interrogated and the physician's tablet worked without difficulties.The physician was not able to state what error message he saw and requested a replacement tablet.The physician's tablet was not replaced, but he was given a new serial cable.Since the time the physician received the new serial cable, the physician's programming system has worked as expected.The complaint serial cable is expected to be returned but has not been received by the manufacturer to date.

Event Description

The complaint serial cable has not been received by the manufacturer to date and is believed to be lost.As the complaint serial cable is no longer expected to be returned, no product analysis will be able to be performed.

• 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: 5214243
• MDR Text Key: 31108678
• Report Number: 1644487-2015-06391
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• 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 11.0.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1