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

Model Number 304-30

Device Problems Therapy Delivered to Incorrect Body Area (1508); Naturally Worn (2988)

Patient Problems Neck Pain (2433); Shock from Patient Lead(s) (3162)

Event Date 10/09/2023

Event Type  malfunction  

Event Description

It was reported that the patient has been experiencing painful shocking sensations in their neck that occurs between their normal cycling and not with normal stimulation, but the intensity of the pain decreased when the settings were lowered.The physician suspected there was a lead issue and as a result the patient underwent a full revision despite all diagnostics being ok when the device was checked.During the surgery it was discovered that there was damage to the lead insulation that was later attributed to trauma from a fall, per the physician.Per the physician, the believed cause of the painful shocking sensations is due to the lead wire damage that occurred from the fall.The full revision was both to preclude serious injury and for patient comfort.No other relevant information has been received to date.

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

The suspect device was received into product analysis for testing.Device testing has not been completed to date.

Event Description

Product analysis completed testing on the suspect device.No other relevant information was 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18065977
• MDR Text Key: 327293174
• Report Number: 1644487-2023-01588
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750153
• UDI-Public: 05425025750153
• 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
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2022
• Device Model Number: 304-30
• Device Lot Number: 5968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• 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: 57 YR
• Patient Sex: Female