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

Model Number MODEL 250

Device Problems Mechanical Problem (1384); Programming Issue (3014)

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

Event Date 10/20/2016

Event Type  malfunction  

Event Description

It was reported that a physician's programming system was having issues.The physician was able to use a back up system, but hers was not operational.The company representative who reported the issue stated that the programming system's serial cable was the issue.No further relevant information has been received to date.

Event Description

Troubleshooting was performed to narrow the cause of the programming issues to the tablet serial cable.The serial cable was unplugged and plugged back in multiple times with no success.After a known good cable was used, the issues stopped, indicating that the interrogation difficulties were due to the serial cable.

Event Description

Further information was provided verifying that the serial cable was discarded after it was identified to be the cause of the issue.No device evaluation is needed because the failure of the serial cable has a known and well understood failure mode.

• 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: 6100209
• MDR Text Key: 60312581
• Report Number: 1644487-2016-02636
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2016

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?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/05/2016; 12/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2014
• 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