MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); High impedance (1291); Naturally Worn (2988)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿migration¿ is not available.(note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event.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 patient fell due to a seizure.The patient¿s mother was unsure if the device was hit during the fall.The patient¿s device is now upside down and the leads are twisted.Physicians disabled the device due to the migration, and the patient underwent a full revision.Patient's implant card was later received which indicated that the reason for replacement was due to high impedance.The explanted suspect device has been received by the manufacturer to undergo product analysis, which has not been completed to date.No additional relevant information has been received to date.

Event Description

Product analysis was completed on the returned lead.It was received in a twisted condition from approximately 130mm to 288mm.This finding is consistent with the patient manipulation/ rotation of the device while implanted.Visual analysis identified a coil break and break mate on the pin coil of the 1st portion.Scanning electron micropscopy (sem) was performed.Coil break end strand 4 was rounded and had extensive pitting.Strand 3 and coil break mate end strand 3 showed signs of stress induced fracture.Though not conclusive, the broken pin coil is likely due to repeated twiddling motion of device.Functional analysis continuity checks of the other returned portions were good with no open circuit conditions.Dried body fluids were observed inside the inner and outer tubes in some areas.No obvious path of fluid ingress was noted other than the abraded openings possibly caused by wear and cut ends.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.Product analysis was also performed on the returned generator.The visual observations are most likely associated with manipulation of the device during the implant/explant procedures.An interrogation and a system diagnostic test were performed.The device output signal was monitored for more than 24-hrs and a comprehensive automated electrical evaluation was performed.No anomalies were seen, and the device performed according to functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.Internal generator data was reviewed.An unexpected reset occurred on 1/10/2022.High impedance was observed in the data at an earlier data than initially reported, and then the impedance fluctuated between normal and high values.Mfr ref #1644487-2023-00361 houses the report of the generator reset.This mdr houses the report of the high impedance on the patient's lead.

Manufacturer Narrative

D9.Corrected whether device was available for evaluation, initial report: inadvertently did not indicate that it was available and list date it was returned to manufacturer medical device problem :a180103.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 16763258
• MDR Text Key: 313524299
• Report Number: 1644487-2023-00477
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

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 Model Number: 304-20
• Device Lot Number: 6923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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): Other
• Patient Age: 30 YR
• Patient Sex: Female