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 09/22/2014

Event Type  malfunction  

Event Description

It was reported that the handheld dell x50 was unresponsive to touch.A hard reset was attempted, but when the align screen prompt was received, the screen was unresponsive to touch.A replacement product was provided.The product has not been received by the manufacturer to date.

Event Description

The handheld and related software were received by the manufacturer for analysis.However, analysis has not been completed to date.It was noted that the handheld was received with a cracked screen, but the company representative reported that it was not cracked prior to shipment.Therefore, it was damaged in the shipping to the manufacturer.

Manufacturer Narrative

Manufacturer device history records were reviewed.Review of the handheld device history record confirmed all quality specifications were passed prior to distribution.

Event Description

An analysis was performed on the returned handheld and software, and the reported allegation could not be verified.The handheld display and touchscreen were damaged during shipping and were no longer functional.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 as previously reported.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.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.

• 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: 4180848
• MDR Text Key: 5097997
• Report Number: 1644487-2014-02731
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• 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: 715919
• Other Device ID Number: VERSION 7.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1