MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Use of Incorrect Control/Treatment Settings (1126); Electrical /Electronic Property Problem (1198); Improper Device Output (2953)

Patient Problems Device Overstimulation of Tissue (1991); Neck Pain (2433)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a company representative attended a patient's clinic visit on (b)(6) 2016.During device diagnostics, the patient experienced pain during stimulation in the neck area and pulled away.The patient would not allow the company representative to interrogate the device to confirm the settings.After the appointment and having left the physician's office, the patient called saying that her device was stimulating about every 30 minutes.The company representative and the patient returned to the physician's office.It was confirmed that the settings had been changed as the output current was 1ma and off time was 60 minutes.The settings were corrected at that time.Additional relevant information has not been received to-date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5815816
• MDR Text Key: 51258316
• Report Number: 1644487-2016-01666
• Device Sequence Number: 0
• Product Code: LYJ
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 11.0.4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR