MAUDE Adverse Event Report: LIVANOVA USA, INC. VAGAL NERVE STIMULATOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)

Model Number M103

Patient Problems Pain (1994); Paralysis (1997)

Event Date 09/18/2023

Event Type  Injury  

Event Description

Patient had vagal nerve stimulator implanted 2018.Now has paralysis left vocal cord.Patient had vagal nerve stimulator (vns) implanted in 2018.This is fda approved treatment for major depression.She now suffers paralysis of the left vocal cord and pain in left ear.Her ent is (b)(6).Reported problem to vns manufacturer, livanova on (b)(6) 2023.

• Brand Name: VAGAL NERVE STIMULATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 17859830
• MDR Text Key: 324871271
• Report Number: MW5146371
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M103
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAPLYTA 42 MG, 1 PER DAY; CLONAZEPAM 2MG; ELECTROCONVULSIVE THERAPY; MONTELUKAST 10MG; VENLAFAXINE 150 MG X 2 PER DAY
• Patient Outcome(s): Disability
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White