MAUDE Adverse Event Report: CYBERONICS INC PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Use of Incorrect Control/Treatment Settings (1126); Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/04/2014

Event Type  malfunction  

Event Description

During review of the in-house programming/diagnostic history database, it was observed that on office visit on (b)(6) 2014 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2014.The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2014.The device was not interrogated prior to the patient leaving the office on (b)(6) 2014 as recommended by device manufacturer to ensure the device is at the correct settings; therefore, the settings were not corrected prior to the patient leaving the office.The settings were corrected on (b)(6) 2014.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 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: 3752090
• MDR Text Key: 19197798
• Report Number: 1644487-2014-01015
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/17/2014

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
• Device Lot Number: 1063524
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 04/15/2014
• 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: 29 YR