MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

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

Patient Problems Pain (1994); Tingling (2171); Twitching (2172)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient was having a tingling sensation in her throat and experienced painful stimulation when a system diagnostic test was performed during an office visit on (b)(6) 2015.It was noted that the system test ¿didn¿t go through.¿ the device was disabled the next day.The tingling sensation resolved after the device was disabled; however, the patient began twitching more.Review of the available programming and diagnostic history showed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during the office visit.The patient had not been ramped up to an output current of 1ma likely due to tolerability issues.As system diagnostic tests run at an output current of 1ma, it is likely that the painful stimulation and tingling sensation were due to the system diagnostic test.The patient was referred for a surgical consult for further evaluation.

Manufacturer Narrative

Review of the available programming and diagnostic history.

Event Description

Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2015.The explanted generator (pulse gen model 101, sn (b)(4)) was returned to the manufacturer for analysis.Monitoring of the device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

• 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: 4851320
• MDR Text Key: 5807653
• Report Number: 1644487-2015-04921
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• 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: 1073771
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR