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 Inflammation (1932); Paralysis (1997); Numbness (2415)

Event Date 02/23/2023

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 from the patient that after their dosing appointment, they have been experiencing numbness on the left side of their body.Patient can observe swelling, veins sticking out of their neck, and feels a sharp, constant pain in their jaw.The patient felt as if they were having a & ;mini-stoke; the nurse recommended the patient stay at the new settings and allow time to adjust to the changes.Patient continued to feel pain and used their magnet to inhibit stimulation.The patient followed up with their nurse the next day asked the nurse to disable the generator, but the nurse only reduced the settings.Patient noted that the swelling in their neck was reduced.The patient is certain they had a & 34;mini-stoke& ; as they have a history of stokes since a car accident from several years ago.Patient later noted feeling pressure behind their left eye.New information was received that the patient swiped their magnet and the stimulation caused temporary paralysis of their vocal chords.The patient followed up with a new neurologist and had their settings adjusted.Device history records were reviewed for the lead.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No other relevant information has been received to date.

Event Description

Information was received from the medical professional that the cause of the reported pressure in the left eye, numbness, and neck swelling is unknown.The cause of the vocal cord paresis is due to the vns stimulation.No other relevant information has been received to date.

• 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: 16573336
• MDR Text Key: 311594245
• Report Number: 1644487-2023-00325
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 01054250257501391
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2023
• Device Model Number: 304-20
• Device Lot Number: 6389
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2019
• 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): Disability
• Patient Age: 72 YR
• Patient Sex: Female