MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Unexpected Therapeutic Results (1631); Improper or Incorrect Procedure or Method (2017)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

It was reported that the patient's generator was found to be programmed to settings different than what were programmed intentionally.It was reported that two patients were implanted on the same day and that the same issue occurred with the first patient.It is believed that a cross-programming event occurred.The first patient was reported in mfr.Report # 1644487-2014-02469.It was reported that the device was programmed back to intended settings and the patient is doing well now.No additional relevant information has been received to date.

Event Description

Additional information was received stating that the vns patient did not experience any lasting symptoms from this event.Additional programming and diagnostic history was provided; however, it did not show the cross programming event and could not be fully assessed due to incorrect time stamps of the programming events.

Manufacturer Narrative

Analysis of programming history.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 4128339
• MDR Text Key: 4791267
• Report Number: 1644487-2014-02511
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2014

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
• Device Lot Number: 1063525
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 09/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1