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

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Difficult to Remove (1528)

Patient Problem Weight Changes (2607)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient's generator would not interrogate with the programming computer.The patient's generator could not be palpated, and it was expressed the patient had a recent gain in weight.Troubleshooting occurred where two different programming systems were used, two different programming wands were used, the batteries in both wands were replaced, and the computer charging cables were removed.The patient could not be moved to a different room to reduce electromagnetic interference.The wands were moved to numerous positions without success.Follow up troubleshooting occurred where suspect devices in the programming systems were switched with known working components, and determined that the issue related to the usb to db9 serial data cable used during the patient's appointment.The cable has not been returned to date, and no additional pertinent information has been received to date.

Event Description

The suspect adapter cable was received by the manufacturer and is undergoing product analysis.It was reported that when the adapter cable was retrieved from the site, it could not be distinguished from the adapter cable reported in medwatch report 1644487-2016-00285.

Event Description

Product analysis was completed on the returned usb to db9 cable.No anomalies associated with the serial cable performance were noted during testing.The serial cable performed according to functional specifications.In particular, all the performed interrogations, programming changes on a test generator, and device diagnostic tests succeeded.The patient's neurologist stated the patient's generator could be successfully interrogated following the initial incident.It was determined that the most likely cause of the previous failure to interrogate was a combination of the usb to db9 cable failure reported in medwatch report 1644487-2016-00285 and electromagnetic interference in the clinical environment where the patient appointment and troubleshooting occurred.No additional pertinent information has been received to date.

• 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: 5464521
• MDR Text Key: 39491665
• Report Number: 1644487-2016-00399
• 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: 02/02/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2016; 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• 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: 17 YR