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

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Skin Infection (4544)

Event Date 11/01/2023

Event Type  Injury  

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.H3.Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined as not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient was scheduled for explant surgery due to an infection.Device history records for the generator were reviewed.The generator was confirmed to have been hp sterilized prior to distribution into the field.The device passed all specifications.No other relevant information has been received to date.

Event Description

Additional information received noting that the patient underwent explant surgery to have their generator and lead removed.Per the physician, the infection was at the lead site and the possible cause was being related to thyroid surgery and the exposure of the leads during that time.Another possible cause was noted to be the loss of the anchor tether attachment causing the lead to migrate.Additional information received noting that the cause of the anchor tether becoming detached is unknown as well as when it became detached.It was noted that the patient had thyroid surgery in september 2022 and then in november 2023 she was noted to have skin opening.The device became infected and was removed completely.Device history records for the lead were reviewed.The lead was confirmed to have been hp sterilized prior to distribution into the field.The device passed all specifications.Device evaluation is not necessary because the reported event has been determined as not related to the functionality or delivery of therapy of the device.

• 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: 19142274
• MDR Text Key: 340570606
• Report Number: 1644487-2024-00440
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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
• Report Date: 05/17/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2014
• Device Model Number: 304-20
• Device Lot Number: 2873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2017
• 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 Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Female