MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Defective Device (2588); Programming Issue (3014)

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

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the nurse practitioner was experiencing issues getting her programming system to function.A company representative performed troubleshooting and isolated the issue to the serial cable.The representative found two faulty serial cables during the troubleshooting.The second cable was reported in mfg.Report #1644487-2016-02175.The physician was provided a new serial cable.The serial cable was received and underwent product analysis.During analysis, the returned serial cable was connected to a known good wand and tablet.The pa lab attempted to interrogate a known good generator with the serial cable however an "unable to open port" message presented.The serial cable's db9 hood was opened it was observed that a wire was no longer soldered on the pcb.The wire was soldered back into place.The lab then successfully interrogated a generator using the serial cable.

• 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: 5973149
• MDR Text Key: 55837690
• Report Number: 1644487-2016-02176
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1