MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE

Model Number	3000-V1.5
Medical Device Problem Codes	False Alarm (1013); Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During a periodic programing history review, high impedance and device disablement was observed for the patient.The cause of the high impedance message was likely a software error on m3000 v1.5.1.2 software; when system diagnostics were performed by the user with m3000 v1.5.2.1 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 other 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: 11529039
• Report Number: 1644487-2021-00378
• Device Sequence Number: 3996836
• Product Code: LYJ
• UDI-Device Identifier: 05425025750429
• UDI-Public: 05425025750429
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2021

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-V1.5
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR