MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 07/21/2016

Event Type  malfunction  

Event Description

It was reported by a nurse at a psychiatrist's office that they were having issues with their handheld programmer.She was able to interrogate one patient but couldn't perform diagnostics.She reported that she saw a message but she couldn't remember what it was.The other patient's device was interrogated, but then the screen froze when she was performing diagnostics.A hard reset of the handheld was performed, but there were no generators available to test the function of the programmer after the reset of the device as the patient had left the office.Additional relevant information has not been received to-date.

Event Description

Follow-up to the physician's office provided that the frozen screen issue had resolved as the programmer was functioning for the patient at their follow-up appointment.The issue experienced performing diagnostics was clarified to have been a faulted systems diagnostics test, which has been reported in medwatch# 1644487-2016-02079.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 5890804
• MDR Text Key: 53455659
• Report Number: 1644487-2016-01885
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

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
• Device Lot Number: 1077278
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2005
• 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
• Patient Age: 60 YR