MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Material Fragmentation (1261); Loose or Intermittent Connection (1371); Communication or Transmission Problem (2896)

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

Event Date 02/01/2016

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2016 that a physician's tablet is not able to communicate with the patient's device or the demo device despite serial cable substitution.It was then noted that the usb port in the tablet was very loose and appeared to have small fragments in the port.It was also mentioned that portions of the exterior were coming off of the tablet.She said that they were able to hold the serial cable firmly in place for a period of time, but now it is no longer working.It was not clear how long the issue had been occurring and if the physician had dropped or accidentally damaged the tablet.The tablet was received on (b)(6) 2016 for analysis.Analysis is underway but has not been completed to date.

Event Description

Product analysis for the tablet was completed and approved on 03/22/2016.An analysis was performed on the returned tablet and during the analysis it was identified that the usb port was damaged.As a result, the tablet was unable to establish communication.Also during the analysis it was identified that a pen drawer socket was damaged.As a result, the pen drawer was not mounted in the tablet case.Both device failures are associated with mishandling of the device.

• Brand Name: PROGRAMMING COMPUTER
• 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: 5513424
• MDR Text Key: 41144689
• Report Number: 1644487-2016-00596
• 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: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• 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: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2014
• 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