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

Model Number MODEL 250

Device Problems Break (1069); Mechanical Problem (1384); Communication or Transmission Problem (2896)

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

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that the physician has tablet issues.The serial cable was swapped with a known good cable and the communication issues with the tablet persisted.The sales representative then used her own tablet with the physician¿s wand and serial cable and stated that the entire system functioned properly.Since this isolated the issue to the tablet it was believed that the usb port may be broken thus causing the programming issues.A hard reset was performed on the tablet however the problem still occurred.It was stated that no patient¿s therapy was affected.The serial cable was stated not to be loose in the port but through isolation of components the tablet was suspected to have the issue.The tablet has not been received for analysis to date.

Event Description

The company representative then returned for further troubleshooting and found that the physician had replaced the depleted 9 v battery with another depleted 9v battery so she placed a new 9v battery into the physician's wand and used it with her programming system.The wand was then able to communicate.The company representative then replaced the physician's white serial adapter with a black serial adapter.The company representative then used the wand and the serial adapter along with the physician's tablet to communicate with a demo generator.It was determined that the previous troubleshooting steps did not fully resolve the communication issues but after testing each component of the physician's programming system with a known good component the issues were identified and resolved.Since this troubleshooting was performed no other communication issues persisted with the physician's device.The white serial cable was then disposed of.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 no other relevant information was received to date.

• 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: 6181465
• MDR Text Key: 62960521
• Report Number: 1644487-2016-02895
• 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: 02/02/2017

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: 12/05/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2015
• 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