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

Model Number MODEL 250

Device Problems Disconnection (1171); Device Inoperable (1663); Communication or Transmission Problem (2896)

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

Event Date 10/14/2016

Event Type  malfunction  

Event Description

It was reported on 10/14/2016 that a nurse was having issues with the tablet communicating with a patients generator.She tried replacing the 9v battery on the wand and tried using a different wand that was connected to her back up (b)(6) hhd but neither fixed the issue.It was also reported that the device wont communicate instantly.The np stated that she will use the hhd device for backup on the patient therefore no patients therapy was affected.Follow-up showed that the cable was swapped for a different cable which resolved the issue.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.

Manufacturer Narrative

Subject device udi: (b)(4).

• 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: 6087800
• MDR Text Key: 59846564
• Report Number: 1644487-2016-02596
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

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
• Other Device ID Number: VERSION 11.0.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2015
• 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