MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE

Model Number	3000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Software version: (b)(4).
Event or Problem Description
It was reported that high impedance and eos-yes end of life message was unexpectedly seen upon interrogation.The high impedance and eos-yes condition resolved when systems diagnostics were performed on the generator the diagnostics showed that the generator was functioning within normal limits.Upon data review, it was determined that some response packets of data received from the generator via the wand were duplicated and/or received out of sequence compared to the prior command packets from the programmer.This resulted in the software incorrectly calculating several values that were received to display.Note that the actual data programmed into the generator was correct and the issue resolved upon re-interrogation.No further relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9573657
• Report Number: 1644487-2020-00062
• Device Sequence Number: 19549918
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/10/2020

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: 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/10/2020
• Patient Sequence Number: 1
• Patient Age: 9 YR