MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/31/2016

Event Type  malfunction  

Event Description

It was reported that the surgeon's programming system was giving errors several times during a vns patient's implant.It was believed the error code was error code 374.The physician reset the buttons on the wand twice and it continued to give an error.He also reportedly used a resistor and that showed the lead was okay, but it could not be determined if this meant the programming system was successfully used at some point in the procedure.Follow up from a company representative attempted to resolve the errors.Standard troubleshooting steps were taken, including verifying that the programming computer was not plugged into the wall ac power, checking the wand 9v battery, and verified connections were tight.Communication with a demo generator was not successful.Several combinations of the existing components and known working components were not successful.The combinations tested aimed to identify a suspect device; however, the results were inconclusive due to inconsistent results.Because the known working components also had mixed success based on the operating environment, electromagnetic interference is suspected to have interfered with the troubleshooting procedure.The suspect device has not been returned to the manufacturer to date.Attempts for additional pertinent information have not been successful to date.

Event Description

The programming system tablet and wand were received by the manufacturer on 07/06/2016.Product analysis was completed on the returned wand on 07/11/2016.Other than normal wear related observations, no external visual anomaly was identified with the serial data cable or case.Internal visual inspection of the printed circuit board assembly and associated components revealed no anomaly.Continuity testing of the serial data cable and the battery cable passed.Furthermore, the returned battery was at a functional voltage level.The device met the specification requirements of the final electrical test and performed according to functional specifications.Product analysis is underway for the returned suspect tablet.Follow up with the physician's office showed that they could interrogate the patient's generator despite the inordinate difficulties in doing so.No additional pertinent information has been received to date.

Event Description

Product analysis was completed on the returned tablet on 07/29/2016.The tablet was received with an ac adapter, sd card, and with the main battery depleted.The tablet was received without a usb to db9 adapter cable.Visual inspection identified no anomalies.No anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.The tablet performed according to functional specifications.The serial adapter cable was reportedly discarded; therefore, product analysis cannot be completed on the unreturned portion.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 5747848
• MDR Text Key: 48837721
• Report Number: 1644487-2016-01405
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/28/2016; 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2014
• 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