MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Loose or Intermittent Connection (1371)

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

Event Date 03/27/2014

Event Type  malfunction  

Event Description

The handheld and flashcard were returned for analysis.Analysis of the handheld was completed on (b)(4) 2014.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.Analysis of the flashcard was completed on (b)(4) 2014.The flashcard and software performed according to specifications.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

Event Description

It was reported that the epileptologist was having intermittent communication issues with his handheld device.The handheld device was freezing during interrogation.It appeared that data was being transferred from the wand but the status bar did not move on the handheld device.The wand battery was changed, soft and hard resets were performed, and the flashcard was reseated; however, the issues were not resolved.Emi is not believed to be a factor.Attempts for product return have been unsuccessful.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution.

• 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: 3763326
• MDR Text Key: 4389971
• Report Number: 1644487-2014-01080
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• 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: 1075837
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1