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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); High impedance (1291)

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

Event Date 05/13/2021

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 from programming history database periodic review that patient was seen with high impedance.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The patient was seen with high impedance again.The physician ordered xrays and reviewed them assessing that a lead fracture is present.The patient is scheduled for full revision surgery.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The explanted lead was received but product analysis is still underway.

Event Description

Patient underwent full revision surgery.The explanted products have not been received by product analysis to date.

Event Description

Product analysis was completed on the returned lead.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.The lead fracture allegations were confirmed in the pa lab.During the visual analysis, the ends of both the ring and pin inner tubes were found to be abraded open, and the coils appeared to be broken at the end of portion.The end of ring coil was dark and appeared to have metal dissolution.Due to the condition of the coil end, the fracture mechanism could not be ascertained.The end of pin coil was dark and pitted and showed signs of a stress induced fracture (fatigue appearance).Continuity checks of the returned lead portion were performed during the functional analysis, and no other discontinuities were identified.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.

• 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: 15993224
• MDR Text Key: 306249659
• Report Number: 1644487-2022-01610
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/07/2023

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: 09/03/2023
• Device Model Number: 304-20
• Device Lot Number: 6389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 03/08/2023; 05/02/2023; 05/30/2023; 07/18/2023
• Supplement Dates FDA Received: 03/30/2023; 05/24/2023; 06/23/2023; 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 36 YR
• Patient Sex: Male