MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

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

Patient Problems Dyspnea (1816); Edema (1820); Paralysis (1997)

Event Date 12/03/2020

Event Type  Injury  

Event Description

It was reported that the patient has had difficulty breathing, and the ent assessed that the patient's vocal cords were swollen.The patient was referred for an mri.Per the physician, the events are due to the presence of the vns device, and the patient will undergo vns revision surgery.Diagnostics were noted to be within normal limits.No known surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

Additional information was received indicating that the patient was experiencing left-sided vocal cord paralysis and underwent lead positioning surgery.The electrodes were placed on a different location on the vagal nerve, and no vns devices were replaced at this surgery.Attempts for additional information regarding the vocal cord paralysis have been made; no additional relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11259164
• MDR Text Key: 229639142
• Report Number: 1644487-2021-00128
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/13/2024
• Device Model Number: 303-20
• Device Lot Number: 205177
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR