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

Model Number 304-20

Device Problems Low impedance (2285); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2019

Event Type  malfunction  

Event Description

It was reported that the patient had low impedance.The patient had x-rays taken and there were no visible fractures per the radiologist.The x-rays have not been received by livanova.Surgery is likely but has not occurred to date.No additional or relevant information has been received to date.

Manufacturer Narrative

Relevant test/laboratory data; corrected data: initial mdr inadvertently did not report settings and diagnostics.

Manufacturer Narrative

Describe event or problem, corrected data: follow-up report #02 inadvertently left out "a review of device history records revealed that the lead passed quality control inspection prior to distribution.".

Event Description

A review of device history records revealed that the lead passed quality control inspection prior to distribution.

Event Description

The patient underwent full vns replacement surgery.The surgeon first replaced the vns generator and tested the impedance.The low impedance did not resolve.After the full revision, all diagnostics were within normal limits.The surgeon noted fractures and fluid incursion into the lead tubing.The explanted products have not been received by the manufacturer to date.

Manufacturer Narrative

Section d.Suspect medical device; corrected information; incorrect device information (model, lot#, expiration date, manufacture date) inadvertently submitted on supplemental mdrs.

• 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: 8426044
• MDR Text Key: 138971600
• Report Number: 1644487-2019-00500
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup
• Report Date: 03/11/2022

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: 10/02/2015
• Device Model Number: 304-20
• Device Lot Number: 201893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 03/18/2019; 04/02/2019; 05/08/2019; 05/20/2019; 03/11/2022
• Supplement Dates FDA Received: 03/18/2019; 04/24/2019; 05/08/2019; 06/13/2019; 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2011
• 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: 17 YR
• Patient Sex: Female