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 12/16/2013

Event Type  malfunction  

Event Description

It was reported that the physician's handheld was unresponsive to the stylus.Troubleshooting was performed.The lock button was not engaged, hard resets were performed and the screen was cleaned.It was reported that the handheld still will not go passed the welcome screen.A new programming tablet was requested and the handheld, flashcard, and programming wand were returned for analysis.Analysis of the programming wand was completed on (b)(4) 2014.Internal visual inspection of the printed circuit board assembly and associated components revealed no anomaly.Continuity testing of the serial data cable and the battery cable passed.The programming wand performed according to functional specifications.Analysis of the handheld and flashcard are underway, but have not been completed to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

• 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: 3567773
• MDR Text Key: 4048152
• Report Number: 1644487-2014-00187
• 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: Physician
• Type of Report: Initial
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• 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: 1073772
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2013
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1