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

Model Number MODEL 250

Device Problems Kinked (1339); Device Displays Incorrect Message (2591)

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

Event Date 10/27/2014

Event Type  malfunction  

Event Description

It was reported that the physician's programming system was giving a "retry" message when trying to interrogate patient's devices.The wand battery was changed and the issue did not resolve.The wand was changed and interrogation was possible.It was later reported that the wand was working fine and that the issue was narrowed down to the usb connector.A new usb connector was used and there were no issues interrogating the generator.The usb was found to be kinked.The usb cable was received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the returned usb adaptor was completed.The cause for the reported allegation is associated with two disconnected wire connections in the returned serial cable.Once the wires were soldered onto the serial cable pcb, no further anomalies were identified.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4277704
• MDR Text Key: 5230077
• Report Number: 1644487-2014-03137
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2014

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 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 11/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1