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

Model Number 3000

Device Problems Application Program Problem: Parameter Calculation Error (1449); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 09/20/2023

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 livanovas 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 an error of high output current was displayed upon interrogating the patients device.The error message noted that the current could not be delivered.It was noted that after re-interrogation, the error went away.It was noted that this error occurred right when device turned from night to daytime settings.Additional information was received noting that the event occurred following a change in day/night settings while the generator was stimulating and that the active output is different from the alternative output currents for day and night settings.Device history records were reviewed for the generator.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No other relevant information has been received to date.

Event Description

Internal generator data was reviewed.The high output current was observed due to the software expecting a 1.5ma output current as the device was initializing its day time programmed parameters.When the physician interrogated the generator the most recent stimulation burst stored within its data was found to be 1.625ma.As the daytime settings was already initialized prior to a stimulation burst occurring with the daytime parameters, the disparity between the most recent stimulation burst of 1.625ma and the expected daytime settings of 1.5ma caused the high output current error message.Subsequent diagnostics were found to be within normal limits.No other relevant information has been received to date.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17927863
• MDR Text Key: 325688541
• Report Number: 1644487-2023-01461
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750443
• UDI-Public: 05425025750443
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 12/18/2023

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: 7060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 12/03/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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: 16 YR
• Patient Sex: Male