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

Model Number 304-20

Device Problem High impedance (1291)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that high impedance was seen upon interrogation.The patient reported painful neck stimulation with their device as well.No trauma or manipulation occurred to the site.The patient was referred to have x-rays taken.Device history records were reviewed.The device passed all functional specifications and quality tests and were sterilized prior to distribution.Ap chest x-ray was received reviewed.The x-rays were provided after report of high impedance.The generator placement appeared to be per labeling in the upper left chest.Based on the images provided, the feedthrough wires were intact, and the connector pin appears to be fully inserted past the backend of the connector block.The visible portion of the lead was reviewed, a strain relief bend and loop are present, however tie down and tie down placement could not be assessed based on the clarity of the image when zooming in.A portion of the lead was visualized behind the generator.Based on the x-rays received, the cause of the high impedance is still unknown.However, any fractures or microfractures on the portions of the lead that were not visible cannot be ruled out.On (b)(6) 2023 the patient underwent a revision due to the high impedance seen on (b)(6) 2023.Pre-op interrogation was conducted in the operating room with the surgeon where it was confirmed that the output current was disabled and impedance was still high.During the procedure, the lead pin was confirmed to be fully inserted and not causing the high impedance.Surgeon reported a small bit of blood inside the lead pin port of the header on the generator but confirmed the header was intact and firmly attached to the generator.The pulled the lead pin out and attempted to reinsert the pin after cleaning it but the resulting impedance was still high.Generator diagnostics were performed with the test resistor indicated impedance of within normal limits and the generator battery was still ok.A new lead was placed to replace the suspect lead and system diagnostic showed impedance within normal limits in the pocket.The surgery was completed with no further issues and the explanted lead was placed in the mail to be returned for product analysis.The lead has not been received to date.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

Device testing was completed by product analysis on the suspect 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: 18136279
• MDR Text Key: 328503597
• Report Number: 1644487-2023-01640
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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: 7436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2022
• 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: 29 YR
• Patient Sex: Female