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

Model Number MODEL 250

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 05/16/2014

Event Type  malfunction  

Event Description

It was reported that the nurse practitioner's tablet usb connection is loose.A new cable was provided which did not resolve the issue.A new programming tablet was provided to the nurse practitioner.The tablet with the loose connection is expected to be returned for analysis, but has not been received to date.

Event Description

The tablet device was returned to the manufacturer for analysis.No anomalies associated with the returned usb to db9 cable were noted during testing.The usb to db9 cable performed according to functional specifications.During the analysis of the returned tablet, it was identified that the usb port was damaged.As a result, the tablet was unable to establish communication and generating port error messages.No further anomalies were identified.

Event Description

On (b)(4) 2014 product analysis was completed on the programming tablet.During the analysis, it was identified that the usb port was damaged.As a result, the tablet was unable to establish communication and generating port error messages.No further anomalies were identified.

Manufacturer Narrative

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

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to 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: 3872943
• MDR Text Key: 4457282
• Report Number: 1644487-2014-01506
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 06/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/10/2014; 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1