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

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 09/15/2020

Event Type  Injury  

Event Description

It was reported that the patient was not talking well and his air was restricted while talking after recently being implanted.The physician believed the discomfort was due to the intubation tube being too big and perhaps it was removed aggressively, and he noted that they think his hypopharynx or vocal cords were traumatized during the surgery.No other relevant information has been received to date.

Manufacturer Narrative

D1, d2, d4.Corrected data, initial report: inadvertently had the generator as the suspect product rather than the lead.H4.Corrected data, initial report: updated manufacturing date for updated suspect product.

Event Description

The device history records of the lead were reviewed.The lead passed final quality and functional specifications prior to release.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
• MDR Report Key: 11147206
• MDR Text Key: 226027491
• Report Number: 1644487-2021-00051
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 02/03/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2024
• Device Model Number: 304-20
• Device Lot Number: 205203
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR