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); Failure to Interrogate (1332); Device Inoperable (1663); Reset Problem (3019)

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

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that the programming handheld was non-functional.It was stated that it "kept locking up and not working while in the room with the patients." it was reported that the sales representative performed troubleshooting and a hard reset on (b)(6) 2016, although this appears to not have resolved the problems.Additional information was received that the issues had been occurring off and on for a few months prior to the initial report.Clarification was received that the issue encountered was actually an alleged screen freeze issue on various screens which caused them to not be able to successfully interrogate patients or change settings.No patients were affected by the issue as the site has back-up programming systems.Furthermore, the issue was reported to have been isolated to the programming handheld as opposed to the wand, as the wand has been successfully used on other programmers.The suspect handheld has not been received by the manufacturer for analysis to date.

Event Description

The handheld device and software was received by the manufacturer, and analysis was completed.No anomalies associated with the handheld performance were noted during testing.The handheld, flashcard and software performed according to functional specifications.

• 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: 5396811
• MDR Text Key: 37349186
• Report Number: 1644487-2016-00168
• 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,Followup
• Report Date: 01/05/2016

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: 1073773
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2012
• 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