MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Looping (1370); Application Program Problem (2880); Calibration Problem (2890); Human-Device Interface Problem (2949)

Patient Problem No Information (3190)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported by a physician that their handheld programmer was not responding to any commands and would not communicate with a patient's device.The company representative visited the site to perform troubleshooting as the device continued to not respond to any inputs.A hard reset was performed and the handheld programmer was then stuck in a looping calibration screen.A replacement tablet was requested for the physician.The handheld has not been received by the manufacturer to-date.Additional relevant information has not been received to-date.

Event Description

The handheld and software were received and analysis was completed on the returned handheld.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.No further anomalies associated with the handheld performance were identified during the analysis.

Manufacturer Narrative

Event description, corrected data: the description of the software analysis was inadvertently not provided in follow-up report #1.

Event Description

Analysis was completed on the returned flashcard and software.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 5816019
• MDR Text Key: 51341570
• Report Number: 1644487-2016-01667
• 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: Initial,Followup,Followup
• Report Date: 07/06/2017

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
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: 06/09/2017; 07/06/2017
• Supplement Dates FDA Received: 07/04/2017; 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2008
• 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
• Patient Outcome(s): Required Intervention