MAUDE Adverse Event Report: CYBERONICS, INC. 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	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect device software version: version 1.0.
Event or Problem Description
Report received that upon interrogating a patient's vns, a physician found that the vns was disabled.The burst watchdog timeout message was reportedly seen.Prior to this, the patient's vns had been programmed on after implant using a programming tablet installed with the m3000, version 1.0 software.At the follow-up appointment.The physician interrogated the device with a programmer installed with m250, version 11 software.It was at this time that the vns settings were found to be disabled.The vns had not been manually programmed off before this.The patient's vns settings were reset to normal parameters after identifying that it had been reset.No further relevant information has been received to date.
Event or Problem Description
Further information was received that the device was found disabled due to burst watchdog timeout at the first interrogation after implant.Further, an error was present for the number of pulses per ramp step for magnet and autostim currents.For magnet stimulation in particular, this would have caused ramp up / down times to extend far enough that a burst watchdog timeout would occur on a magnet stimulation.Output current was turned back on with the v11 tablet, which resulted in correction of the pulse count calculations.No further relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 7105057
• Report Number: 1644487-2017-04971
• Device Sequence Number: 1895617
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/15/2018

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: 11/16/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR