MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 04/19/2016

Event Type  malfunction  

Event Description

It was reported on 04/19/2016 that a physician's programming software would not work.The company representative was attempting to extract data, but the device froze on the start-up screen.The battery was replaced, but the issue continued.The programming software version could not be provided as the device was frozen on the start-up screen.The handheld and flashcard are expected to be returned for analysis, but have not been received to date.

Event Description

The handheld and flashcard were received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the handheld was completed on 07/01/2016.No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.The handheld performed according to functional specifications.Analysis of the flashcard was completed on 07/01/2016.The flashcard file system "as received" was found to be corrupt.As a result of the file system corruption, the flashcard was unreadable and could not load the vns software onto the handheld.Once the flashcard was formatted and new installation software was copied onto the flashcard, no anomalies associated with the flashcard performance were identified during the flashcard analysis.It was also identified that the 2577 folder was inaccessible using a pc computer and the cyberonic sbu.Cdb and archive database (b)(4) files were 0kb in size.These anomalies are an indication that the files and folder on the returned flashcard are also corrupt.It is generally unknown when or how the flashcard files were corrupted based on the available information, although the corrupt files do show a modification date of (b)(6) 2015 (assuming that the date on the handheld was correct at the time of the event).

• 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: 5658066
• MDR Text Key: 46572921
• Report Number: 1644487-2016-00969
• 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: 04/19/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/27/2016; 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2005
• 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