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

Model Number 304-20

Device Problems Fracture (1260); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2020

Event Type  malfunction  

Event Description

It was reported that the patient had high impedance observed.It was noted that the physician did not suspect any injury caused the damage.No known surgery has occurred to date.No additional relevant information has been received.

Event Description

Patient had a full revision performed.During surgery, it was reported that the original leads had no tiedowns present and the distal coil was not attached to the vagus nerve.Per the surgeon, the lead detachment was due to no tie down being placed by the previous surgeon.The explanted devices were discarded.No additional 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
• MDR Report Key: 11140676
• MDR Text Key: 225839961
• Report Number: 1644487-2021-00040
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2022
• Device Model Number: 304-20
• Device Lot Number: 204373
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR