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

Model Number MODEL 250

Device Problems Bent (1059); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

It was reported that there was physical damage to the physician¿s programming tablet that occurred on (b)(6) 2014.It was reported that the usb cable for the programming wand would not connect to the tablet usb port due to the port being bent.It was reported that no patient's were affected because another programming system was available.It was reported that the tablet was used the day prior without any difficulty and placed back in locked storage after use.It is unknown if any mishandling occurred.A new programming tablet was provided to the physician.The tablet was received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the programming tablet was completed on (b)(6) 2014.During the analysis, it was identified that the usb port was damaged.As a result, the tablet was unable to establish communication and generating port error messages.No further anomalies were identified.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the programming tablet 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 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: 4115931
• MDR Text Key: 4935183
• Report Number: 1644487-2014-02465
• 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,Followup
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1