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

Model Number 304-20

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Contamination with Body Fluid (2317); Naturally Worn (2988)

Patient Problems Shock from Patient Lead(s) (3162); Implant Pain (4561)

Event Date 09/18/2023

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

It was reported that the patient was experiencing painful stimulation at the neck site.Therefore, the patient underwent a revision surgery to correct this pain.During this surgery, liquid was observed inside the lead sheath resulting in no devices being exchanged during the surgery.The device was left in place and turned off.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient was seen for a consultation and no more discomfort has been felt since the repositioning revision surgery of the lead attachment wing.Impedances were noted to be good and the patient has tolerated increasing of the settings.No further surgery has been planned.The lead was not nicked and the cause of the fluid leaks is unknown.The painful neck stimulation has been assessed to the presence of the vns device as the pain felt by the patient was probably due to mechanical pressure exerted by a lead attachment wing.After repositioning the lead attachment wing, the patient no longer felt any pain.No images were taken.

• 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: 17913730
• MDR Text Key: 325408392
• Report Number: 1644487-2023-01457
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 304-20
• Device Lot Number: 7173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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 Age: 39 YR
• Patient Sex: Male