MAUDE Adverse Event Report: LIVANOVA USA, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 3000

Device Problems False Alarm (1013); Fracture (1260); Application Program Problem: Parameter Calculation Error (1449)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2019

Event Type  malfunction  

Event Description

Programming history database periodic review was performed and confirmed a high impedance event for the patient.High impedance was seen on.Patient underwent generator replacement but no known lead replacement has occurred to date.No additional relevant information has been received to date.

Event Description

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.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 v1.5.2.1 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 additional relevant information has been received to date.

Manufacturer Narrative

B5.Corrected information, section d corrected information; information inadvertently omitted that was known prior to submission of mdr.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12804809
• MDR Text Key: 285411504
• Report Number: 1644487-2021-01576
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup
• Report Date: 12/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2015
• Device Model Number: MODEL 3000
• Device Lot Number: 2940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male