MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Device Problems Improper or Incorrect Procedure or Method (2017); Programming Issue (3014)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

During review of the manufacturer¿s programming history database, it was identified that a programming anomaly occurred sometime between (b)(6) 2011 and (b)(6) 2016 from a faulted system diagnostic test.Upon initial interrogation on (b)(6) 2016, unintended settings were found.Clinic notes dated (b)(6) 2015 reported: "the parameters look like the initial set up numbers of the vns.So will need to reprogram from scratch once her battery is changed.¿ initially at that time, it was interpreted that this meant failure to program due to end of service which was reported in mfr report #: 1644487-2016-00829.Based on the new programming history available on 05/19/2016, it appears that the physician likely identified the faulted system diagnostic setting parameters.A physician note dated (b)(6) 2015: reported "2012 without feeling device." no additional relevant information has been received to date.

Event Description

Upon follow-up, the last known reporting physician was unable to provide any clarifying information.No additional relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 5730841
• MDR Text Key: 48463430
• Report Number: 1644487-2016-01370
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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