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

Model Number MODEL 250

Device Problems Failure to Advance (2524); Operating System Version or Upgrade Problem (2997)

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

Event Date 10/30/2014

Event Type  malfunction  

Event Description

It was reported that the physician's handheld was unable to advance past the "clear all data from memory" screen.Hard resets were performed, but the handheld would still not advance.The battery was removed and reinserted, but this did not resolve the issue.Additional troubleshooting was performed by ensuring the correct key was being pressed, the screen lock was not engaged and the battery cover latch was closed.The flashcard was reinserted; however, the issue did not resolve.It was reported that the handheld was initially able to be used with the version 7.1 software, but was unable to be upgraded to the 8.1 software and after a hard reset was performed the issue occurred.It was reported that the physician has multiple other programming systems so no patients were affected.The handheld is expected to be returned for analysis, but has not been completed to date.

Event Description

The handheld was received by the manufacturer.An analysis was performed on the returned handheld, nd the reported allegation of being unable to complete a hard reset was confirmed.An analysis was performed on the returned handheld and the reported allegation was verified.The cause for the complaint is associated with a loose cable on the main board that caused the contacts button to be nonfunctional.Since the button was not functioning, a hard reset could not be completed.Once the cable was reseated, the contacts button functioned as expected and a hard reset was performed with no anomalies.The flashcard and software performed according to functional specifications.

Manufacturer Narrative

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

• 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: 4281117
• MDR Text Key: 5035504
• Report Number: 1644487-2014-03158
• 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: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• 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 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1