MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

Model Number MODEL 250

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the physician's programming system was not working.No patients were affected since the office had another programming system available.A company representative determined that the serial cable was defective.The physician was provided with a new serial cable.The defective serial cable was discarded therefore product analysis cannot be completed.

Event Description

It was reported that troubleshooting included replacing the serial cable which resolved the issue with the programming system.As previously reported in mfg report #0 the serial cable was discarded.However, 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, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 5986610
• MDR Text Key: 56469484
• Report Number: 1644487-2016-02228
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1