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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

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 & #39;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 & #34;defects¿ or & #34;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 the patient was being referred to their surgeon due to high impedance being observed following a full revision.The report adds that there are multiple coils within the wire extending from the generator to the neck which were not seen prior.Additionally, no lead discontinuities were identified and the connection of the lead to the generator could not be confirmed.A chest ap x-ray was received for review.Based on the image provided, no anomalies that would indicate a device malfunction were identified.The cause of the high impedance cannot be determined; however, because the generator was recently implanted, it is possible that the connector pin may not be fully inserted.Note that the presence of lead and microfractures cannot be ruled out.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The suspect lead was received for analysis.No other relevant information has been received to date.

Event Description

Information was received that the patient underwent a lead revision.Per the surgeon the high impedance was likely due to a fracture as the patient is a twiddler.Information was also received that the patient was bleeding more than usual and was suspected to be due to a leaking vessel which required help from the vascular surgery team.The vascular team prepared for a blood transfusion, but only additional iv fluids were required.Response was also received from the surgeon.Per the surgeon, the bleeding was excessive and due to the vns surgery.The explanted device has not been received to date.

Event Description

Product analysis for the returned lead was completed.

• 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: 16787495
• MDR Text Key: 313765695
• Report Number: 1644487-2023-00498
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 0105425025750139
• 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: 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 Model Number: 304-20
• Device Lot Number: 7131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 06/09/2023; 08/21/2023; 09/21/2023
• Supplement Dates FDA Received: 06/30/2023; 09/15/2023; 10/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male