MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number 250

Device Problems Computer Software Problem (1112); Energy Output To Patient Tissue Incorrect (1209)

Patient Problem Seizures (2063)

Event Date 11/15/2016

Event Type  malfunction  

Event Description

A physician reported that a patient was having an increase in seizures and when he came into the office, his vns device was found to be programmed off for an unknown reason.No warning messages were received on the programming software.No additional relevant information has been received to date.

Event Description

Information was received that the patient's vns device was turned back on and the patient's seizure activity has decreased.Programming data was received from the physician however the patient's serial number is not known at this time so the data could not be reviewed for the patient's device.

Event Description

The patient's product information was received so the programming data could be reviewed for the patient.It was found after a programming history review that there was a failed diagnostic test which resulted in the patient's device being inadvertently disabled.The disablement of the device is what led to the increase in seizures for the patient since the disablement was not caught until a later date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS, INC.; 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: 6658075
• MDR Text Key: 78104643
• Report Number: 1644487-2017-04023
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR