MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure of Device to Self-Test (2937)

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

Event Date 09/05/2011

Event Type  malfunction  

Event Description

During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2011 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2011.The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2011.The physician corrected some settings; however, the device pulse width, off time, magnet output current and magnet on time were not corrected.The device was interrogated prior to the patient leaving the office on (b)(6) 2011 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct these settings back to previous settings.No patient adverse events were reported.

Manufacturer Narrative

Analysis of programming history.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS; 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: 4063976
• MDR Text Key: 4815436
• Report Number: 1644487-2014-02259
• 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
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• 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: 840999
• Other Device ID Number: VERSION 8.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR