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

Model Number MODEL 250

Device Problems Device Displays Incorrect Message (2591); Difficult to Open or Close (2921)

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

Event Date 02/09/2015

Event Type  malfunction  

Event Description

It was reported that the representative's handheld was experiencing a failure to open port message.It was reported that the problem is always resolved through persistence of use.The representative was provided a new usb cable and the non-functioning usb cable was received for analysis.Analysis is underway, but has not been completed to date.

Event Description

This initial report from the sales representative was for 3 different serial cables.When the serial cables were returned to the manufacturer for analysis it was found that it was unable to determine which serial cable was associated with which tablet device.Therefore, when product analysis was completed and approved for the 3 tablet serial cables one showed a failure while the other 2 performed according to specification.It is unknown exactly which tablet is associated with the malfunctioning cable.Mdr # 1644487-2015-04117 will house the serial cable with the malfunction and mdr # 1644487-2015-04101 will house the other tablet serial cable report.This mdr will house one of the cables where no failure was found.Product analysis for the serial cable for tablet (b)(4) was completed and approved on 03/23/2015.An analysis was performed on the returned usb to db9 cable and the reported allegation was not verified.No anomalies associated with the usb to db9 cable were noted during testing.The usb to db9 cable performed according to functional specifications as evaluated through 38-0004-3700.

• 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: 4591774
• MDR Text Key: 5481655
• Report Number: 1644487-2015-04118
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2015

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 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 03/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1