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

Model Number MODEL 250

Device Problems Break (1069); Component Falling (1105); Defective Component (2292); Material Protrusion/Extrusion (2979); Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that a physician's entire programming system was dropped while in a bag.The usb connection on the tablet was broken as a result and it was noted that it had "only 4 pins sticking out of it." the tablet turned on but was unable to program, and the wand was tested with a different programming system but was unable to work.Analysis confirmed wand failure which will be reported on a regulatory summary report.Prior to being dropped, the programming system was functioning properly.The wand lights stay on for at least 25 seconds, ruling out a power problem.Therefore, the causes of the issues were due to user handling at that time.Analysis of the tablet was completed on 05/18/2016.During the analysis of the tablet, it was identified that the returned serial cable was defective.The cause for the anomaly is associated with a broken wire connection in the serial cable db9 hood assembly.Once the wire was soldered on to the pcb, no further anomalies associated with the tablet performance were noted except for the reported usb port damage on the tablet.

• 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: 5718544
• MDR Text Key: 48198582
• Report Number: 1644487-2016-01252
• 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: 05/18/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2015
• 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