MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Device Operates Differently Than Expected (2913); Programming Issue (3014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2010

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) 2010, the patient's settings were different than what were programmed at the same office visit.The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2010.The physician corrected the settings; however, the magnet on time was not corrected.The device was interrogated prior to the patient leaving the office on (b)(6) 2010 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct the magnet on time back to the previous setting.No patient adverse events were reported.

Manufacturer Narrative

Analysis of programming history.

Manufacturer Narrative

Serial #, corrected data: previously submitted mdr inadvertently did not provide the correct serial number of the suspect device.It is now known.This report is being submitted to correct this data.Lot #, corrected data: previously submitted mdr inadvertently did not include this information.This report is being submitted to correct this data.Manufacture date, corrected data: previously submitted mdr inadvertently did not include this information.This report is being submitted to correct this data.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 4063702
• MDR Text Key: 4900064
• Report Number: 1644487-2014-02256
• 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,Followup
• 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: 678293
• Other Device ID Number: VERSION 7.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR