MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Computer Operating System Problem (2898)

Patient Problem No Information (3190)

Event Date 12/18/2015

Event Type  malfunction  

Event Description

It was reported that a medical professional was having difficulties with her programming system.The flashcard of a handheld computer was no longer supporting the program.It was reported that the handheld computer could not perform any task with its flashcard.By using others flashcards, it was functioning perfectly.Troubleshooting and hard reset were performed without success.Review of manufacturing records confirmed that the handheld computer passed all functional tests prior to distribution.The handheld computer and the flashcard were returned to the manufacturer on (b)(6) 2016.Analysis are underway but they have not been completed to date.

Event Description

Analysis of the returned flashcard / software was completed and the reported allegation was verified.During the analysis it was identified that the 2577 installation folder was missing.As a result, the vns software could not be installed into the handheld using the returned flashcard.Additionally, it appears that the contents of the vns81.Arm.Cab (located in the 2577 folder) had been extracted to the root directory of the flashcard.In addition to the.Cab files, (b)(4).The origin of the files is unknown.No other anomalies were identified.Analysis of the returned handheld computer was completed and no anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.The handheld performed according to functional specifications.

• 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: 5366189
• MDR Text Key: 36348289
• Report Number: 1644487-2016-00104
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

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: 1063824
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2012
• 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