MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Seizures (2063)

Event Date 07/15/2014

Event Type  malfunction  

Event Description

It was observed during a review of the manufacturer's in house programming history data that the patient was inadvertently programmed to 60 minutes of off time resulting in a low therapy level.This was the result of a faulted systems diagnostics test on (b)(6) 2014 that reprogrammed the device.The settings were then re-programmed on (b)(6) 2014 to correct the faulted diagnostics test, however the off time of 60 minutes was not corrected.An increase in seizure activity below the pre-vns baseline was reported and it was attributed by the medical professional to be due to the unintentional sub-therapeutic levels due to the vns off time being too high.No additional relevant information has been received to-date.

• 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: 5486316
• MDR Text Key: 40209199
• Report Number: 1644487-2016-00497
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• 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: 1063825
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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: 18 YR