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

Model Number 250

Device Problems Failure to Interrogate (1332); Programming Issue (3014)

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

Event Date 11/04/2016

Event Type  malfunction  

Event Description

It was reported by the physician's office they were unable to interrogate a patient's device during an office visit.On (b)(6) 2016, a company representative went to the office and the patient had been brought back in to have the vns checked.It was noted the company representative was easily able to check the vns and there were no issues.However, when attempting to use the physician's programming system, there were unable to interrogate the device and continued to get a communication error.Troubleshooting was performed, in the form of switching out programming wands and checking cables, which was able to isolate the handheld programming computer as the cause of the programming issues.Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Suspect medical device: software version number 8.1.

Manufacturer Narrative

This information was inadvertently reported in correctly on supplemental #02 mfr.Report.

Manufacturer Narrative

This information was inadvertently reported incorrectly on supplemental #01 mfr.Report.

Event Description

The device was received by the manufacturer for analysis.While analysis is expected, it has not been completed to date.

Event Description

Product analysis (pa) for the returned handheld device (hhd) was completed.During analysis, it was identified that the hhd was unable to advance past the screen alignment utility.The cause for the display anomaly is associated with the resistance values being higher than expected in the touch screen circuitry.No further anomalies associated with the hhd performance were identified during analysis.Pa for the returned software was completed.Testing of the software confirmed there were no corruptions, no anomalies, and the software performed as intended.

• 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: 6136223
• MDR Text Key: 61494226
• Report Number: 1644487-2016-02754
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/27/2017

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: 250
• Device Lot Number: 1063829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2016; 03/14/2017; 03/14/2017; 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2013
• 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