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

Model Number MODEL 250

Device Problems Communication or Transmission Problem (2896); Connection Problem (2900)

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

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported on (b)(6) 2016 that the physician's tablet was having trouble communicating with a 0 bytes message relaying on the screen.The tc performed troubleshooting and verified that the wand battery stayed on over 25 seconds.He verified that the tablet was not connected to the wall.He did not try removing and re-inserting the serial cable.The physician tried re-positioning the wand over the generator and the wand was away from other sources of electrical equipment.The patient being interrogated left without a successful programming but will come back for follow-up.The physician was adamant that the patient's device was not faulty or at end of service because he had just interrogated her successfully shortly prior to that visit and everything was working fine.The physician was given an extra black serial cable to see if that may resolve the issue at the next appointment for a patient.The black cable did resolve the issues.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: 5978175
• MDR Text Key: 55941627
• Report Number: 1644487-2016-02200
• 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
• Report Date: 09/01/2016

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: 09/01/2016
• Initial Date FDA Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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