MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number 250

Device Problems Failure to Interrogate (1332); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/14/2016

Event Type  malfunction  

Event Description

It was reported by the company representative that the patient had come in for a vns replacement surgery.Upon interrogation of the device, the settings were found to be indicative of a faulted diagnostic test.It was explained to the surgeon that the settings found during interrogation were indicative of a faulted diagnostic test.The neurologist's physician's assistant was notified and stated the last time the checked the device was (b)(6) 2016 and he was able to provide the intended settings.The physician's assistant noted that when performing diagnostics on that date, the patient had a weird tightening sensation in her chest, so the diagnostics were interrupted.Due to the patient's tightness, they were unable to perform a final interrogation to verify the settings.It was explained to the physicians at that time that the patient would have been programmed at the unintended settings since (b)(6) 2016 until the day of surgery (2 weeks).After the implant was complete, the surgeon decided to program the patient back to the intended settings.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS; 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: 5913259
• MDR Text Key: 54069063
• Report Number: 1644487-2016-01951
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 250
• Other Device ID Number: VERSION 11.0.4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/01/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR