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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arrhythmia (1721); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Headache (1880); Incontinence (1928); Memory Loss/Impairment (1958); Muscle Weakness (1967); Pain (1994); Vertigo (2134); Vomiting (2144); Nasal Obstruction (2466); Constipation (3274); Convulsion/Seizure (4406); Unspecified Vascular Problem (4441); Unspecified Eye / Vision Problem (4471); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/07/2022

Event Type  Injury  

Event Description

Vns implant manufactured by liva nova induced seizures, shortness of breath, headaches, vomiting, incontinence, constipation, vertigo, digestive tract disruption, vision pain and weakness, swelling, memory loss, poor circulation, chest palpitations, difficulty swallowing and breathing, nasal polyps and swelling, hoarseness, pressure in brain, etc.Product is implanted in body.Seizure disorder due to implant.Fda safety report id (b)(4).

• Brand Name: SENTIVA¿
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 15462591
• MDR Text Key: 300471278
• Report Number: MW5112190
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/19/2022

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: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2022
• Patient Sequence Number: 1
• Treatment: KEPPRA, NEUROSTIMULATOR DEVICE.
• Patient Outcome(s): Hospitalization; Disability; Required Intervention; Other; Life Threatening
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American