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 Arrhythmia (1721); Pain (1994)

Event Date 10/14/2019

Event Type  Injury  

Event Description

A clinical study site reported that the patient was having a serious adverse event of rapid heart rate that may possibly be related to stimulation.It was later clarified that the event of rapid heart rate was actually throat discomfort which was assessed to be a serious injury.The patient was also indicated to have a serious adverse event of atrial fibrillation that may be associated with stimulation.No additional relevant information has been received to date.

Event Description

The information received indicates the atrial fibrillation is not related to vitaria implant and not related to vitaria stimulation.It was indicated the event was probably related to the patient's underlying disease.The only action taken was the patient using the magnet to interrupt magnet stimulation and medication/hospitalization.It was indicated that the event has recovered/resolved.

Event Description

Additional information was received that the event of arterial fibrillation is no longer recovered/resolved from the clinical study team.

Manufacturer Narrative

Date of this report - initial mdr report indicated it was submitted on 11/06/2019 however the date should have indicated 11/11/2019.Event description - correction - inadvertently did not include the information received that the throat discomfort was downgraded and indicated to no longer being a serious adverse event.

Event Description

Additional information was received regarding the throat discomfort indicated to be related to vns stimulation.The only action taken for this adverse event was stated to be using the magnet to interrupt stimulation.No treatment for the patient was affected.The adverse event of throat discomfort was also updated and indicated that it was not a serious adverse event.The magnet was also used to inhibit stimulation for the adverse event of atrial fibrillation.The atrial fibrillation was indicated to probably be related to the patient¿s underlying diseases and throat discomfort was possibly related.The atrial fibrillation has resolved.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9304263
• MDR Text Key: 166760602
• Report Number: 1644487-2019-02158
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2020

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: 11/07/2016
• Device Model Number: 7103
• Device Lot Number: 204721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 12/02/2019; 01/23/2020; 03/02/2020
• Supplement Dates FDA Received: 12/05/2019; 02/14/2020; 03/27/2020
• 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): Other