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

Model Number MODEL 250

Device Problems Bent (1059); Device Inoperable (1663); Communication or Transmission Problem (2896); Mechanical Jam (2983)

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

Event Date 04/28/2016

Event Type  malfunction  

Event Description

It was reported that the physician has somehow damaged the usb drive in the tablet and that now the adapter won't stay in the tablet usb drive and the system won't function because of it.The consultant stated that it looks like the usb cable may have been jammed into the usb slot and may have bent the pins.Now the usb cable doesn't stay in and the system doesn't work/communicate anymore.The tablet was received for product analysis on 5/12/2016.Product analysis is still underway and has not yet been completed.

Event Description

On (b)(6) 2016 product analysis was completed on the tablet.During the analysis, it was identified that the usb port was damaged; bent connector pins; exact cause is unknown but appears to be a user-related event.As a result, the tablet was unable to establish communication.Once the damaged port was replaced with a known good port, no further anomalies were identified.

• 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: 5673627
• MDR Text Key: 46294936
• Report Number: 1644487-2016-01100
• 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: 04/28/2016

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
• Other Device ID Number: VERSION 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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