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

Model Number MODEL 250

Device Problems Intermittent Continuity (1121); Operating System Becomes Nonfunctional (2996)

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

Event Date 08/01/2014

Event Type  malfunction  

Event Description

It was reported by the physician the handheld programmer had issues with the screen freezing over the past year, intermittently, while checking patients.It was noted the handheld had to have a hard restart multiple times.The physician has requested a replacement and the physician was provided a new programming tablet.The handheld programmer is expected to be returned to the manufacturer, but has not been received to date.

Manufacturer Narrative

This information was originally incorrectly reported on the initial mfr.Report.

Event Description

The handheld device and related software were received on 09/23/2015.Product analysis is expected but has not been completed to date.

Event Description

Analysis for the returned handheld device revealed no anomalies were noted during testing using the ac adapter or the main battery with a full charge.The handheld device performed according to functional specifications.Analysis for the returned software was completed and confirmed the event of the screen freezing during interrogation.The screen freezing is a known issue that has been previously investigated by the manufacturer and the root cause was determined to be due to a failure in the api function that results in control of the device not returning to the cyberonics software.The most probable cause is an anomaly in the interface between the microsoft provided software and the dell hardware which results in the os's inability to locate specific memory directories within the file system.No additional issues were observed with the returned flashcard.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: 5050242
• MDR Text Key: 25430500
• Report Number: 1644487-2015-05641
• 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: Physician
• Type of Report: Followup,Followup
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• 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: 1073773
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/20/2015
• 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
• Patient Age: 60 YR