MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Bent (1059); Communication or Transmission Problem (2896)

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

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that the physician is having a problem with a tablet.The physician states there is a bent pin where the usb cable goes in which is causing the usb serial cable to not be able to communicate with the wand.The associated serial cable was discarded.The tablet has not been received for analysis to date.

Event Description

Tablet was received for analysis on 03/30/2016.Product analysis for the tablet was completed and approved on 04/20/2016.An analysis was performed on the returned tablet and 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.Visual inspection identified no anomalies.No bent pins in the usb port were identified.Two known good serial cables were tested on the tablet during initial troubleshooting which did not work on the old system.The wand was also confirmed to be functioning properly.Therefore, it is unknown what may have caused the communication issues with the tablet port.

• 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: 5515342
• MDR Text Key: 41147540
• Report Number: 1644487-2016-00615
• 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: 02/25/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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