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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

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 referred for a full revision.Programming history database was reviewed for this patient's generator, which showed high lead impedance.Patient later went into surgery and high impedance was seen during pre-op checks.It is unknown if they attempted pin re-insertion before replacing the generator.And only had a generator replacement.Impedance was on the higher end but still within normal limits.Patient was later seen in clinic where impedance was high again with low output current.The patient is being referred for x-rays.X-rays have not been reviewed by manufacturer to date.Product return attempt will not be made for explanted generator, as listed facility is a no return site.No known additional relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information was received that the patient underwent a revision surgery where the lead was replaced.The explanted product has not been received into product analysis to date.No other relevant information has been received to date.

Event Description

The explanted lead was received into product analysis.Analysis has not been completed to date.

Event Description

Lead pa was later completed.The lead assembly was returned for analysis due to lead fracture, which was confirmed in product analysis.During the visual analysis of the 1st portion, the ring coil appeared to be broken at end of portion, the coil break mate was not returned.The broken end appeared dark, pitted and rounded.Due to the condition of the coil end the fracture mechanism could not be ascertained.In addition, coil1 of 3rd portion was found to be broken.The coil break end is dark and pitted; the coil break mate end is dark, pitted and shows signs of metal dissolution.Due to the condition of the coil ends the fracture mechanism could not be ascertained.Continuity checks of the returned lead portions were performed during the functional analysis, and no other discontinuities were identified.Abrasions and fluid were observed in several places in the inner and outer tubing of the lead.No other anomalies were noted.Other than the conditions noted above, and the abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

• 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: 16234133
• MDR Text Key: 309029748
• Report Number: 1644487-2023-00081
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/16/2016
• Device Model Number: 304-20
• Device Lot Number: 3497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 02/17/2023; 03/07/2023; 04/17/2023
• Supplement Dates FDA Received: 03/10/2023; 03/30/2023; 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2012
• 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
• Treatment: EMPTY
• Patient Age: 16 YR
• Patient Sex: Female