MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number	MODEL 3000
Medical Device Problem Code	Incorrect Software Programming Calculations (1495)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Upon interrogation of the generator, it was noticed that the generator settings were reset, which was not expected.It was determined that the new programming system was not used and that the warning message seen was a burst watchdog warning.Due to burst watchdog, the settings upon interrogation were at 0 ma on (b)(6) 2017 instead of the previously programmed output current of 0.25 ma.This burst watchdog timeout event is believed to be due to a software error in the model 3000 programmer that causes certain parameters to be incorrectly calculated in m106 generators.This occurred because, while the patient was set to a 0.25 ma normal mode output current and 0.5 ma magnet output current, the patient's frequency was changed by a model 3000 programmer without a subsequent programming step to adjust magnet or autostimulation output current.The patient was programmed back on with a model 250 tablet.No further relevant information has been received to date.
Additional Manufacturer Narrative
Corrected data: initial reported inadvertently listed #34;3000-v1.0 instead of model 3000.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 7205954
• Report Number: 1644487-2018-00118
• Device Sequence Number: 13634054
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 01/19/2018; 03/13/2019
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/13/2018; 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR