MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure of Device to Self-Test (2937)

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

Event Date 09/03/2015

Event Type  malfunction  

Event Description

During review of the in-house programming history database, it is suspected that a faulted system diagnostic test occurred after (b)(6) 2015.On (b)(6) 2015 a system and normal mode diagnostics were performed.A final interrogation was performed confirming the correct settings.On the next recorded office visit, the settings were found to be at unintended parameters.The device was programmed to intended settings on (b)(6) 2014.No patient adverse events were reported.

Event Description

Additional information was received from the physician assistant that patient's change in settings due to computer software error occurred on (b)(6) 2015.The physician assistant mentioned that she had trouble interrogating the patient's device on (b)(6) 2015.She was able to interrogate the settings initially but was unable to program.She performed troubleshooting by replacing the cables, securing cable connections and replacing the tablet/handheld devices.She then identified the issue to be due to wand battery depletion by performing the battery test.When the 9v wand battery was changed, the patient's generator was able to be programmed.The change in the patient's device settings were corrected the same visit.Product information was requested but were not provided.

• 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: 5355510
• MDR Text Key: 35792712
• Report Number: 1644487-2016-00065
• 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: 12/18/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• 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
• Patient Age: 61 YR