MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Programming Issue (3014)

Patient Problem Pain (1994)

Event Date 09/22/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient was seen in clinic on (b)(6) 2014 for a vns follow-up visit; system diagnostics were performed and the patient experienced pain at the electrode site with stimulation.No changes were made to the patient¿s device settings during the office visit.The patient reported that when he swipes his magnet, he feels the same pain.The patient returned to the clinic on (b)(6) 2014 and the device magnet current different than what was previously programmed.No further information relevant to the event has been received to date.

Manufacturer Narrative

Brand name, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.Type of device, name, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.Model #, serial #, lot #, expiration date, other, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, these fields are being updated to reflect the suspect medical device.Operator of device, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the user of the suspect medical device.If implanted, give date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.If explanted, give date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.Device manufacture date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.Labeled for single use, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.Usage of device, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.

• 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: 4207463
• MDR Text Key: 4983837
• Report Number: 1644487-2014-02853
• 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: Consumer,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/01/2014

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 Expiration Date: 09/30/2005
• Device Model Number: MODEL 250
• Device Lot Number: 3673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 10/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR