MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problems Failure to Deliver Energy (1211); Output below Specifications (3004); Physical Resistance/Sticking (4012)

Patient Problems Convulsion, Clonic (2222); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2023

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 when interrogating a patient's device it was found that the output current was not being delivered.The patient was then seen again and their device was programmed to 0ma and then reprogrammed on and when a system diagnostics was performed it still showed that the current was not being delivered.No other relevant information has been received to date.

Event Description

Additional information received that when trying to alter the patient's settings, all attempts were unsuccessful and the changes were not accepted.The patient was experiencing an increase in seizures therefore they underwent a battery replacement and there were no issues with the newly implanted generator.The explanted generator has not been received to date.Internal data from the suspect generator was received and reviewed.Internal investigation into confirmed cases was unable to determine a definitive root cause of reed switch failures.The primary root cause is believed to be reed switches sticking in the closed position after extended exposure to magnetic fields.The investigation also identified residual magnetic properties of the generator battery to be a potential contributor; however, testing performed during the investigation found the effect to be highly variable with each magnetic field exposure and any closure of the reed switch impacted by this phenomenon would likely be reversed by subsequent swiping of the patient magnet.Thus, the most likely contributor of the identified complaints is considered to be mechanical sticking of the reed switch blades.

Event Description

Additional information received noting that nothing unusual happened to the patient on (b)(6) 2023 and the increase in seizures was above pre-vns baseline levels.The explanted generator was received but product analysis is still underway.

Event Description

Product analysis was completed on the returned generator.An interrogation and a system diagnostic test were performed.The device output signal was monitored for more than 24-hrs.During the 24-hour output signal monitoring period the magnet current did not maintain as programmed.After a magnet swipe, with a livanova magnet, the magnet current did not activate, and the output signal only returned after the dut was tapped.The magnet was applied again, magnet current did not activate, and the output signal did not resume even though the dut was tapped.A comprehensive automated electrical evaluation (shows an ifi=no condition) was performed.The reed switch failure allegation was confirmed in the pa lab.Other than the reed switch stuck closed condition, the device performed according to functional specifications.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• 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: 17152658
• MDR Text Key: 317682432
• Report Number: 1644487-2023-00784
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2023
• Device Model Number: 1000
• Device Lot Number: 6928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 07/21/2023; 08/30/2023; 10/11/2023
• Supplement Dates FDA Received: 08/15/2023; 09/21/2023; 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2021
• 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 Outcome(s): Required Intervention