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

Model Number 304-20

Device Problems Fracture (1260); High impedance (1291); Material Twisted/Bent (2981)

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

Event Date 08/25/2023

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 by the physician that high impedance and low output was observed.Later an implant card was received indicating full revision surgery.Reason initially noted as 'prophylactic' with no reason for lead revision indicated, however this was later confirmed to be incorrect.In pre-op, the generator read ok battery life.When the new lead was connected to the generator the battery showed end of service.The surgeon elected to then replace the generator.Per the company representative, electrocautery was used however it is unknown if it came into contact with the generator.Ap chest x-ray was received and reviewed.The x-rays were provided after report of high impedance and premature end of service.The generator placement was assessed to be normal per labeling.However, based on the quality of the image decreasing when zooming in, complete pin insertion, and feed thru wire integrity are unable to be assessed.The lead could not be completely assessed based on the quality of the image.Strain relief, tie downs and determination of lead route behind the generator are not able to be assessed.There appears to be a sharp corner in the lead, highlighted by the yellow arrow.This cannot conclusively be determined to be a fault/cause of the high impedance due to the image quality.Based on the x-rays received, the cause of the high impedance is unknown at this time.The physician indicated that the sharp corner appears to be a fracture to them, however due to the quality of the image customer quality could not confirm if it was in fact a fracture.Any fractures or microfractures on the portions of the lead that were not visible cannot be ruled out.Device history records were reviewed the patient's generator.The device passed all functional specifications and quality tests and were sterilized prior to distribution.Emdr medwatch 1644487-2023-01837 was created to house the report of premature end of service for the generator.

Manufacturer Narrative

A2 age at time of event, corrected data: the initial reporter inadvertently used the incorrect age.

Event Description

Device testing was completed.Additional information received confirmed high impedance occurred prior to previous report.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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18375233
• MDR Text Key: 331361901
• Report Number: 1644487-2023-01836
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2020
• Device Model Number: 304-20
• Device Lot Number: 203906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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: 16 YR
• Patient Sex: Female