MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number	MODEL 3000
Medical Device Problem Code	Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the patient's device was interrogated a burst watchdog timeout warning was seen and all outputs were set to zero.The patient's device was programed on after implant with a programing tablet installed with m3000 v1.0 software.At a follow-up appointment, the patient was interrogated and a burst watchdog timeout warning was seen and all outputs were set to zero.The device was programed back to the previous, normal settings.The data from the tablet with m3000 v1.0 software has been received for analysis.Analysis of the data has been completed and confirms the event is due to a programming software issue that would leave the patient's device susceptible to a burst watchdog timeout.No further relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 7144294
• Report Number: 1644487-2017-05067
• Device Sequence Number: 939125
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR