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

Model Number MODEL 250

Device Problems Crack (1135); Device Inoperable (1663)

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

Event Date 06/06/2014

Event Type  malfunction  

Event Description

The company representative reported that he went to use his handheld and the screen was cracked.He reported that the screen was no longer responsive due to the crack and a hard reset did not resolve the issue.It was reported that the handheld had not been handled roughly and it is unknown how the screen became cracked.The company representative was provided a new programming computer and the handheld was returned for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the handheld was completed on (b)(4) 2014.A visual analysis of the handheld was able to verify that the display was cracked.The cause for the cracked screen is associated with mishandling of the device.Once the screen was replaced with a known good screen, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.Once the screen was replaced, no further anomalies associated with the handheld were noted during testing.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.

• 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: 3913728
• MDR Text Key: 4513973
• Report Number: 1644487-2014-01700
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 250
• Device Lot Number: 1063834
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1