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

Model Number 3000

Device Problems Application Program Problem: Parameter Calculation Error (1449); Low impedance (2285)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

It was reported that when the patient was seen in clinic they presented with low impedance.The patient was then seen in clinic again and their lead impedance was found to be within normal limits.No other relevant information has been received to date.

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

The patient was seen in clinic again and their impedance remains within normal limits.

Event Description

Internal testing and data review identified that false low output current messages can occur when the autostim threshold is changed during the 15 minute temporary test.Once the user programs on day/night settings, the programmer will instruct the ipg to start using night mode settings for the temporary (15 minute test).If any settings not related to stimulation parameters (current, on time, off time, etc) are changed, the programmer will command the ipg to stop the temporary test and the ipg will re-eneter day mode settings.When a system diagnostics is performed, the programmer errantly compares the diagnostics results (which were run with daytime stim parameters) against nighttime settings even though ipg is in day mode.Since night time stim (2.5ma) is higher than day time stim (2ma), this is interpreted as low output current.Based on the reported programming sequence that occurred that day, it was consistent with the false low output current mechanism described above.Therefore, the patient's generator is expected to be able to deliver therapy as programmed.

Event Description

Reviewing log files, it was found that during the programming event that occurred right after enabling day/night mode, the prone position detection was enabled and the low heart rate threshold was changed to 50 bpm.It is known that if any settings not related to stimulation parameters (current, on time, off time, etc) are changed, the programmer will command the ipg to stop the temporary test and the ipg will re-enter day mode settings.When a system diagnostics is performed, the programmer errantly compares the diagnostics results (which were run with daytime stim parameters) against nighttime settings even though ipg is in day mode.

• 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: 15963529
• MDR Text Key: 306089491
• Report Number: 1644487-2022-01597
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750535
• UDI-Public: 05425025750535
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2023

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: Lay User/Patient
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 01/16/2023; 03/15/2023; 06/12/2023
• Supplement Dates FDA Received: 02/10/2023; 04/10/2023; 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• 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