MAUDE Adverse Event Report: LIVANOVA USA, INC. VITARIA GEN MODEL 7103; GENERATOR

Model Number 7103

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

Patient Problems Syncope (1610); Nausea (1970); Tachycardia (2095); Vomiting (2144); Dizziness (2194)

Event Date 12/05/2019

Event Type  Injury  

Event Description

It was reported that the patient had postural dizziness with pre-syncope.It was indicated that this was considered a serious adverse event that was probably related to the presence of the implant and possibly related to stimulation.Additional details were received indicating that it was determined by the physician to probably be related to the vitaria implant due to the patient having intermittent nausea since the vitaria implant.The physician also determined that it was possibly related to the vitaria stimulation as the event occurred within an hour of the patient's settings being increased.The patient was provided with medication and was hospitalized.The event has now recovered/resolved.No additional relevant information has been received to date.

Event Description

Anthem reconciliation report was received and reviewed.The patient's weight was provided.The medication that was provided was cvm1: amiodarone.A brief summary was provided indicating the patient was seen in clinic for titration visit per study protocol.Patient tolerated the titration and has no complaints.A few minutes after the patient left the clinic, he experiences severe nausea with vomiting and feeling light headed.The patient was then taken to the ed and admitted for observation.The patient was then discharged after stable condition.

Event Description

Report received from clinical study site that the patient had vomiting/palpitations at the same time as the other events.The report indicated that the palpitation and vomiting were mild and required no intervention.Both events were recovered/resolved.Events were noted not to be serious.It was noted that the events started right after titration.Events were possibly related to stimulation.No further relevant information has been received to date.

• Brand Name: VITARIA GEN MODEL 7103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 9553854
• MDR Text Key: 173790107
• Report Number: 1644487-2020-00040
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/07/2020; 12/16/2021
• Supplement Dates FDA Received: 01/29/2020; 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 77 KG