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

Model Number MODEL 250

Device Problems Bent (1059); Loose or Intermittent Connection (1371); Mechanical Problem (1384); Failure to Power Up (1476); Device Inoperable (1663); Malposition of Device (2616)

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

Event Date 02/03/2014

Event Type  malfunction  

Event Description

Additional information was received stating that the handheld device was most likely dropped or misused and the button may have been repositioned incorrectly.

Event Description

It was reported that the physician's tablet does not power on when the power button is pressed.It was reported that the tablet charges, but does not power on.Troubleshooting performed by a company representative identified that the power button did not feel like it was engaging when pressed.It was reported that the physician has two other tablets so no patients were affected by this.The tablet was returned for analysis.Analysis of the tablet was completed on (b)(4) 2014.During the analysis, it was identified that the tablet¿s power button was installed upside down.As a result, when the power button was pressed, the post on the power button was striking the power board led and not the on/off switch.Further analysis of the power button also identified that one of the legs were bent.The bent leg allowed the power button to be loose inside the tablet and also made it easy to remove (as compared to a known good tablet).This condition most likely allowed to power button to be accidently removed from the tablet.When the button was replaced, it was most likely positioned upside down.No further anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3677268
• MDR Text Key: 4220978
• Report Number: 1644487-2014-00683
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2014

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 10.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 03/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1