MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 02/19/2016

Event Type  malfunction  

Event Description

A nurse reported on (b)(6) 2016 that the physician's handheld experienced a frozen screen after interrogating a patient's device.The company representative reported that she was at the office on (b)(6) 2016, tested the handheld by interrogating with two different generators and it worked fine.She was performing training with a physician.However, the reporter called again on (b)(6) 2016 reporting that the physician had to go "through many steps" to properly interrogate the patient who had been seen in clinic lately, but the patient was eventually interrogated.She describes the issue as "being able to interrogate device but it freezes." she did not have a specific message or screen which was being displayed.She said the physician told her "it should show treatment parameters but it does not" and was not sure if she was providing us with the right information.Since then, however, this device is still locking up upon interrogation.She requested that the company representative re-visit, and acknowledged that the programmer worked properly during her visit on (b)(6) 2016.Based on the company representative's conversation with the site, the issue was rising from interrogating a patient directly from the parameter screen of a different patient rather than exiting to the main menu.The company representative went to the site and found the programming settings for the first patient that was seen, and therefore, she believes that it was a cross-programming event between the two generators.If they were interrogating a patient directly from the parameter screen from a different patient (rather than exiting to the main menu), this could result in a cross-programming event if the model of the generators was the same (and were m100-m102/m102r).No additional relevant information has been received to date.

Manufacturer Narrative

Date received by manufacturer (mo/day/yr), corrected data: supplemental mdr 1 inadvertently had the wrong date received date.Correct date for supplemental mdr 1 is 05/13/2016.

• 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: 5505045
• MDR Text Key: 40783157
• Report Number: 1644487-2016-00570
• Device Sequence Number: 1
• Product Code: MUZ
• 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,Followup,Followup
• Report Date: 02/19/2016

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
• Device Lot Number: 1077285
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/13/2016; 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2013
• 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