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

Model Number MODEL 250

Device Problem Device Inoperable (1663)

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

Event Date 06/11/2014

Event Type  malfunction  

Event Description

The handheld and flashcard were received for analysis.Analysis of the handheld was completed on (b)(4) 2014.During the analysis it was identified that the handheld was received with the lock button in the locked position.Since the lock button was locked, the handheld buttons and touchscreen were unresponsive.Once the lock button was moved to the unlocked position no anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.Analysis of the flashcard was completed on (b)(4) 2014.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

Additional information was received stating that the hospital staff was well trained in proper usage of the handheld.The handheld device was programmed off and intentionally returned with the lock button engaged.

Event Description

Additional information was received clarifying that the handheld device had a frozen screen and was not responding to the user.The handheld device is expected to be returned to the manufacturer for analysis but has not been returned to date.

Manufacturer Narrative

Lot #, corrected data: previously submitted mdr incorrectly reported this information.

Event Description

It was reported that the physician's handheld does not respond to any command and has self behave.It is unknown if troubleshooting was performed.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 3892490
• MDR Text Key: 4723289
• Report Number: 1644487-2014-01581
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• 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: 1063833
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1