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

Model Number MODEL 250

Device Problems Charging Problem (2892); Programming Issue (3014)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that a medical professional was having difficulty to use her programming system.It was reported that her handheld computer could not keep the charge anymore.Despite of a constant plug, the light was still orange and warning.A new motion tablet was sent to the medical professional as a replacement.She reported later that everything is now ok.The suspected handheld computer was not returned to the manufacturer to date.

Event Description

The suspected handheld computer and the flashcard were returned to the manufacturer on 10/24/2016.An analysis of the returned handheld computer was completed and the reported allegation ¿battery failure, will not hold charge¿ was not verified.No anomalies associated with the main battery were identified during the analysis.During the analysis it was verified that the handheld would not power on.The cause for the anomaly is associated with an open electrical connection in the power portion of the serial cable.As a result of the open wire connection, the handheld was unable to receive power from the ac adapter.No other anomalies were identified.An analysis of the returned flashcard was completed and no anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

• 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: 5959422
• MDR Text Key: 55379817
• Report Number: 1644487-2016-02120
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

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
• Device Lot Number: 1063524
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2012
• 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