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

Model Number MODEL 250

Device Problems Intermittent Continuity (1121); Device Inoperable (1663); Failure to Align (2522)

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

Event Date 08/01/2014

Event Type  malfunction  

Event Description

It was reported that the neurologist¿s handheld device would respond intermittently at various screens.A hard reset was performed (b)(6) 2014 and the handheld subsequently was unable to pass the alignment screen.The unresponsive handheld device has not been returned to date.

Event Description

The handheld device and software flashcard were returned to the manufacturer for analysis.No anomalies associated with the touchscreen performance were identified during the analysis.During the analysis, it was identified that the handheld was returned without a battery cover.As a result, the handheld would not power on.Once a known good battery cover was installed, the handheld performed according to functional specifications.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: 4084110
• MDR Text Key: 4850281
• Report Number: 1644487-2014-02320
• 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
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• 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: 1073773
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1