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	10/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was revealed during review of the manufacturer's programming history database, a false abnormal diagnostics message was observed on a diagnostics test performed mid-session (i.E.Not upon initial interrogation).The diagnostics were within normal limits with system diagnostics performed within the next few minutes.The abnormal diagnostics falsely indicated low output current, high impedance, and low battery.Upon further investigation, 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: 8404754
• Report Number: 1644487-2019-00451
• Device Sequence Number: 2326044
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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: 3000
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/08/2019
• Patient Sequence Number: 1
• Patient Age: 14 YR