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

Model Number MODEL 250

Device Problems Image Display Error/Artifact (1304); Failure to Power Up (1476)

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

Event Date 07/24/2015

Event Type  malfunction  

Event Description

It was reported that the physician's tablet would not power on.Once the tablet finally did power on, the screen was noted to be full of lines.The complaint tablet was received on (b)(6) 2015.The physician was provided a new programming tablet.Device analysis is underway but has not been completed to date.

Event Description

Product analysis was performed which showed the cause of the reported power on issues was associated with an upside down power button.Once the power button was installed correctly, no further anomalies associated with the tablet were identified.The dhr was reviewed and it was noted the device passed all functionality tests and inspection.

Manufacturer Narrative

The udi # was inadvertently left of the original mfr.Report; (b)(4).

• 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: 5027315
• MDR Text Key: 24796923
• Report Number: 1644487-2015-05603
• 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
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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