MAUDE Adverse Event Report: CYBERONICS INC PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 09/11/2009

Event Type  malfunction  

Event Description

A review of programming and diagnostic data was performed.On (b)(6) 2009, a faulted system diagnostics test changed the generator parameters to unintended settings.The changed settings were first observed on (b)(4) 2010.The settings were not corrected until (b)(6) 2011.

Manufacturer Narrative

Analysis of programming history.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS INC; 100 cyberonics blvd; houston TX 77058
• 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: 3552226
• MDR Text Key: 18806366
• Report Number: 1644487-2014-00070
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial
• Report Date: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 7.1
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/05/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR