MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Device Operates Differently Than Expected (2913); Reset Problem (3019)

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

Event Date 08/20/2015

Event Type  malfunction  

Event Description

It was reported that the physician was experiencing freezing issues with his vns handheld programmer.The handheld computer was restarted using a hard reset and also a battery-out reset.This did not resolve the issue.No patients were affected.No additional relevant information has been obtained to date.The handheld programmer has not been received by the manufacturer to date.

Event Description

Additional information was received that the psychiatrist had received the replacement tablet.Prior to this, the psychiatrist was still having issues with the handheld programmer.No additional relevant information has been obtained to date.

Event Description

The vns programming handheld and software were received by the manufacturer for analysis.However, analysis has not been completed to date.

Event Description

Analysis of the returned handheld vns programming computer was completed.During the analysis it was identified that the handheld was unable to advance past the screen alignment utility.The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry.Following replacement with a known good screen, full product functionality was restored.No further anomalies associated with the handheld performance were identified during the analysis.Analysis of the returned software was also completed which showed no anomalies associated with flashcard software or databases.The flashcard and software 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: 5074272
• MDR Text Key: 26159310
• Report Number: 1644487-2015-05776
• 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: Followup,Followup
• Report Date: 08/20/2015

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: 1077282
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/24/2015; 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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