MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Disconnection (1171); Communication or Transmission Problem (2896)

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

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a company representative that he was having difficulty communicating with a patient¿s generator at the beginning of a surgery.It was determined to be an issue with the white usb serial data cable.The programming tablet was being held up by a mayo stand and the cable was hanging from the tablet over the edge of the mayo stand.The wand was held far enough away to where the connection cable was taut.The tablet was moved further up the mayo stand such that the cable was supported and the issue resolved at that time, however the issue persisted after that surgery.The white usb serial data cable was replaced with a new black usb serial data cable and the problem was reported to have been resolved.Additional relevant information has not been received to-date.The serial cable does not require return, as the failure mode is understood to be a failure of the serial cable associated with a disconnected wire connection.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6168122
• MDR Text Key: 62434930
• Report Number: 1644487-2016-02842
• 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: Other
• Type of Report: Initial
• Report Date: 11/17/2016

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: Other
• Device Model Number: MODEL 250
• Other Device ID Number: VERISON 11.0.4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2015
• 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