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

Model Number MODEL 250

Device Problems Device Damaged Prior to Use (2284); Human-Device Interface Problem (2949)

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

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a physician's tablet has a damaged usb port.The company representative who was informed of the issue said that she could observe that one of the prongs is damaged and that the usb cable cannot be inserted because of the damaged port.The office thinks someone may have forcefully put the usb cable in incorrectly, but it wasn't clear when this happed.No patients were affected as they have two other dosing systems to use for their patients.This was noted to be a "recent" issue.The tablet is expected to be returned but has not been received to date.

Manufacturer Narrative

Corrected data: version 11.0.Initial mdr inadvertently did not list the software version.

Event Description

The tablet was received on (b)(6) 2016.An analysis was performed on the returned tablet and the reported allegation of hardware failure was verified.During the analysis it was identified that the usb port was damaged.As a result, the tablet was unable to establish communication.No further anomalies were identified.A review of device history records for the tablet shows that no unresolved non-conformances were found.

• 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: 6012434
• MDR Text Key: 57103614
• Report Number: 1644487-2016-02287
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2014
• 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