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

Model Number 304-20

Device Problem Fracture (1260)

Patient Problems Nerve Damage (1979); 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 that patient was seen with high impedance and has been referred for surgery.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was later reported that the high impedance was due to the fall which ruptured the electrode.The entire system was explanted as the left vagus nerve was also injured.Patient is scheduled for re-implant.The physician assessed that the damage to the electrode is due to the patient's fall.Assessment of nerve damage was not provided.The explanted device has not been received to date.No other relevant information has been received to date.

Event Description

It was later reported that the physician has assessed the cause of the nerve damage was due to the patient's fall in the bathroom.No other relevant information has been received to date.

Event Description

Product analysis was completed on the patient's explanted generator and it was discovered that high impedance was seen at an earlier date than initially reported.The date of event has been updated.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: 18253648
• MDR Text Key: 329567431
• Report Number: 1644487-2023-01698
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2021
• Device Model Number: 304-20
• Device Lot Number: 204075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/03/2023
• Supplement Dates Manufacturer Received: 01/17/2024; 02/26/2024; 05/01/2024
• Supplement Dates FDA Received: 02/09/2024; 03/22/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• 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 Outcome(s): Disability; Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male