MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/02/2016

Event Type  malfunction  

Event Description

During review of the in-house programming history database, it was observed that a faulted system diagnostic test occurred on (b)(6) 2016.The device was interrogated then programmed.However, the off time of 60 minutes was not corrected back.The magnet mode stimulation was also left on.The treating physician was informed of the software error and the importance reprograming the device to intended settings when necessary.The physician was informed to verify that the patient's magnet mode output current is 0 ma for patients receiving vns therapy for depression.

Event Description

Patient's settings were adjusted back to intended settings.

• 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: 5744757
• MDR Text Key: 48835311
• Report Number: 1644487-2016-01419
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 05/25/2017

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: 521381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2006
• 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
• Patient Age: 76 YR