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 Pocket Erosion (2013); Scar Tissue (2060); Post Operative Wound Infection (2446)

Event Date 11/22/2023

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.

Event Description

It was reported that superficial scarring was observed on the patient's neck at the incision site following their implant procedure.It was noted that the patient was referred for surgery to address the scarring.No device issue was observed.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information was received noting that the reported event is less of a scarring concern but a possibility of an infection.This was noted to not yet be confirmed.Patient was noted to be referred for surgery but is on hold since patient is improving.The possible infection was noted to be patient related and not the device.More information was received from the physician noting that there was no scarring.Device history records were reviewed for the device.The device passed all functional specifications and quality tests and was hp sterilized prior to distribution.Device evaluation is not necessary because the reported event has been determined to be related to the implant procedure no other relevant information has been received to date.

Manufacturer Narrative

H3.Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined to be related to the implant procedure.

Event Description

The patient's mother reported that the hardware was exposed and the patient was referred for explant surgery.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

B5 describe event or problem, corrected data: supplemental #02 report inadvertently left out relevant information f10 adverse event problem, corrected data: supplemental #02 report inadvertently left out code 'e1713' g2 report source , corrected data: supplemental #02 report inadvertently did not select 'consumer'.

Event Description

Additional information was received noting that the patient is no longer getting an explant as their condition has improved.No other relevant information has been received to date.

Event Description

Additional information received noting that the patient had their generator and lead explanted.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: 18332245
• MDR Text Key: 330546704
• Report Number: 1644487-2023-01797
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/18/2024

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: Health Professional
• Device Model Number: 304-20
• Device Lot Number: 787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/27/2023; 01/29/2024; 03/15/2024; 03/26/2024
• Supplement Dates FDA Received: 01/19/2024; 02/21/2024; 03/15/2024; 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2023
• 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: 13 YR
• Patient Sex: Female