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

Model Number MODEL 250

Device Problems Crack (1135); Failure to Power Up (1476)

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

Event Date 07/11/2014

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Analysis of returned tablet device was completed.A visual inspection of the tablet verified that the display was cracked.No anomalies associated with the software or battery was identified during the analysis.

Manufacturer Narrative

Evaluation codes: no device failure occurred that would contribute to the computer powering down during use.User interface caused the crack in the screen; however, the crack did not inhibit use of the computer.

Manufacturer Narrative

Event Description

It was reported that during surgery, the tablet kept shorting out and would power down while attempting device interrogation.A second programming tablet was used to successfully interrogate that patient's device.It was reported that the tablet had been accidentally dropped some time ago which caused a small crack in the screen, but this was not believed to cause the sudden power down.The programming tablet was received for analysis.Analysis is underway, but has not been completed to date.

• 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: 3995031
• MDR Text Key: 15956551
• Report Number: 1644487-2014-01977
• 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,Followup
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• 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: 07/16/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR