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

Model Number MODEL 250

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

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

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

Unique device identifier: (b)(4).

Event Description

It was reported that the company representative's tablet was displaying a communication error and did not have a good connection.The company representative's wand was confirmed to be working after being used with a known working tablet, and the company representative's serial cable was replaced but did not resolve the problem.The company representative reported that something in the port seemed off level and that she thought that something in inside the port wasn't lining up.She said she had to hold the serial cable in to get her programming system to work.No additional relevant information has been received to date.The suspect product has not been received by the manufacturing facility to date.

Manufacturer Narrative

(b)(4).

Event Description

The suspect tablet was returned to the manufacturer without the accompanying usb-serial adapter for product analysis.Interrogation and programming was performed by the tablet multiple times without communication issue.The tablet was able to complete testing with no other observed anomalies.Per the company representative, the unreturned usb-serial adapter associated with the suspect tablet was reportedly able to be used with other tablets with no issue.No further relevant information has been received to date.

• 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: 6068989
• MDR Text Key: 59036240
• Report Number: 1644487-2016-02516
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

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: Other
• 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: 01/12/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• 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