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

Model Number MODEL 250

Device Problems Intermittent Continuity (1121); Communication or Transmission Problem (2896)

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

Event Date 11/11/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 it was reported that the physician's tablet was having intermittent communication issues.The physician was not able to use the system at all on the patient in the office at that time however the therapeutic consultant was able to use his dosing system on the patient with no issues.The serial cable on the tablet was removed and then reinserted with no resolution of the communication issues.The 9v battery was checked and confirmed to remain on for >25 seconds.The tablet was not plugged into the wall during use.The therapeutic consultant confirmed that when his wand and serial cable were substituted on the tablet, he was getting intermittent issues as well.When he used the physician's wand and serial cable with his tablet he was able to successfully communicate with his demo product after an initial communication error.The tablet was returned for product analysis on (b)(6) 2015.Product analysis is still underway and has not yet been completed.

Event Description

Product analysis was completed on the tablet on 12/16/2015.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.

• 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: 5270935
• MDR Text Key: 33293279
• Report Number: 1644487-2015-06660
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

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: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• 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