MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Failure to Align (2522); Operating System Becomes Nonfunctional (2996)

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

Event Date 09/01/2014

Event Type  malfunction  

Event Description

An analysis was performed on the returned flashcard and the reported allegation was not verified.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

Manufacturer Narrative

Suspect medical device lot #, corrected data: the supplemental report #1 inadvertently did not report this information.Device manufacture date, corrected data: the initial report inadvertently reported this incorrectly.

Event Description

It was reported that the physician reported that the handheld device was malfunctioning.It was reported that the handheld screen was freezing upon interrogation.Troubleshooting, including hard resets, reportedly did not resolve the issue.A replacement device was provided to the site.The handheld and related software has not been received by the manufacturer to date.It was also reported that the handheld screen would not align, which is reported in mfg report #: 1644487-2014-02794.

Event Description

The suspect device was received by the manufacturer for analysis.However, analysis has not been completed to date.

• 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: 4195523
• MDR Text Key: 5047421
• Report Number: 1644487-2014-02795
• 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,Followup
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• 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: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/17/2014
• 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