MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Disconnection (1171); Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

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

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the physician was experiencing intermittent communication issues with his programming system.Troubleshooting included confirming that the wand¿s 9v battery was functioning properly and it was confirmed that the tablet was not plugged into the wall outlet.The physician was eventually able to program however since the issues were intermittent it was noted to be difficult.A company representative later went to the physician¿s office and performed troubleshooting.It was then confirmed that the issue resolved after the serial cable was replaced.The suspect serial cable was discarded.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 COMPUTER
• 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: 6172766
• MDR Text Key: 62616456
• Report Number: 1644487-2016-02854
• 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: Physician
• Type of Report: Initial
• Report Date: 11/22/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1