MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/01/2014

Event Type  malfunction  

Event Description

Analysis of the handheld was completed on 01/05/2015.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 01/05/2015.An analysis of the handheld and flashcard software identified that the cyberonicsbu.Cdb database and 6 archive databases were corrupt.Further analysis identified that all the corrupt databases were 344kb in size, giving the indication that the archive databases are copies of the original corrupt cyberonics database.A root cause for file corruption could not be identified based on the available information.No further anomalies were identified.

Event Description

It was reported that the while attempting interrogations, the handheld device showed "vns therapy error.Error executing sql statement." a hard reset was performed and the software flashcard was reseated; however, the issue did not resolve.The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 4367119
• MDR Text Key: 5422920
• Report Number: 1644487-2014-03467
• 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: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• 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: 1073772
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1