MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Disconnection (1171); Failure to Interrogate (1332); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a company representative that a physician was unable to interrogate a patient¿s vns.After troubleshooting was performed, it was reported the issue was still not resolved and a message was displaying as ¿unable to read position of the wand¿.The white usb serial data cable was changed to a new black usb serial data cable and the problem was resolved.The cable was discarded.Additional relevant information has not been received to-date.The serial cable does not require return, as the failure mode is understood to be a failure of the serial cable associated with a disconnected wire connection.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6159065
• MDR Text Key: 62383472
• Report Number: 1644487-2016-02827
• 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
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• 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: 11/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2015
• 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