MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 3000

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2020

Event Type  malfunction  

Event Description

During periodic programming history review, high impedance was observed when v1.5 software was used on a m102 generator.System diagnostics were initially performed which caused the false high impedance to be observed.Normal mode diagnostics were performed soon after and showed high lead impedance but dcdc code 0.The impedance was likely stored from the previous system diagnostics.It was determined that the cause of this false high impedance message was a software error on m3000 (b)(4) software; when system diagnostics were performed by the user with m3000 (b)(4) software on m102/102r generators (normal mode output current >0 ma), normal mode diagnostics would actually be performed instead.The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds.No additional relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 10876763
• MDR Text Key: 218227780
• Report Number: 1644487-2020-01571
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750429
• UDI-Public: 05425025750429
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2020

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
• Device Operator: Health Professional
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR