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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317); Naturally Worn (2988)

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

Event Date 09/21/2023

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

During a battery replacement surgery, the patient's electrode was found to be broken but will be changed in the future.The lead impedance was noted to be high.No known surgical intervention has occurred to date with the lead.No other relevant information has been received to date.

Event Description

Additional information received noting that the patient underwent a full revision surgery.When attempting to remove the lead from the generator, a piece was left behind and had to be manually removed.The suspect device has not been received to date.It was also noted that the lead damage was caused by patient manipulation, twiddling.

Event Description

Additional information received noting that the patient experienced swelling and pain over the implant site and an ultrasound noted a pocket of fluid over the device.Product analysis was completed and the suspect lead.Other than the reddish-brown deposits, abraded openings, coil breaks, and lead body twisted appearance, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.

Event Description

The suspect product was received but product analysis is still underway.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17944957
• MDR Text Key: 325799459
• Report Number: 1644487-2023-01481
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/23/2024

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 Expiration Date: 10/17/2021
• Device Model Number: 304-20
• Device Lot Number: 204281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 01/18/2024; 03/01/2024; 03/29/2024
• Supplement Dates FDA Received: 02/12/2024; 03/26/2024; 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• 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: 26 YR
• Patient Sex: Male