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

Model Number 3000

Device Problems Application Program Problem: Parameter Calculation Error (1449); Output below Specifications (3004)

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

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova;s employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any defects¿ or malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that a physician was trying to program a patient's day/night mode and continually received an error message stating, "15 minute test interrupted." a low output warning message was also seen.The wand connection troubleshooting was performed, but the error message was still present.Then the tablet was reset and diagnostics were ran.Results were within normal limits.The physician attempted to enable day/night mode again, and the same error message was seen.However, the schedule was enabled and the parameters were set as physician had intended.Physician left the session and was able to change normal parameters successfully.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Internal testing and data review identified that cause of the false low output current messages.The site enabled day/night mode and initiated the 15 minute temporary test however there was a break in communication which resulted in the software thinking the device was in night mode when it was in day mode.As the nighttime output current was higher than the daytime output current, the device returned low output when diagnostics were performed (interrogation not performed prior to diagnostics).After the 15 minute test, the event resolved and the low output message cleared.There is no device issue suspected and the intended amount of therapy was being delivered.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 16334191
• MDR Text Key: 309608709
• Report Number: 1644487-2023-00132
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750535
• UDI-Public: 05425025750535
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

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: 3000
• Device Lot Number: 7377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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: 11 YR
• Patient Sex: Male