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

Model Number MODEL 250

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

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

Event Date 02/11/2015

Event Type  malfunction  

Event Description

It was reported that the handheld device showed a "check sum¿ error message.It was confirmed that there were no issues with the wand battery.The handheld was not plugged into the power outlet and a hard reset did not resolve the issue.Interrogation was attempted in a different area of the room but the issues continued.The components of the programming system were switched out but the source of the issue could not be located.The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.

Event Description

Product analysis was completed for the handheld device and software flashcard.No anomalies associated with the handheld device or software flashcard were noted during testing.The handheld device and software flashcard performed according to functional specifications.Information was received that the issue was resolved with the new tablet.The handheld device serial cable will not be returning for analysis.

Manufacturer Narrative

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4582152
• MDR Text Key: 5340925
• Report Number: 1644487-2015-04090
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• 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: 1073773
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1