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 Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/06/2019

Event Type  Injury  

Event Description

It was reported that a patient would be missing a titration session due to hospitalization related to patient hypotension.No further relevant information was received to date.

Event Description

Further information was received from a third party managing the clinical study this patient is a part of.It was stated that the event date is noted to be 3(b)(6) 2019 and end date is (b)(6) 2019.It was stated the adverse event is severe, not related to vitaria implant or stimulation, and definitely related to underlying disease with rationale "the patient fell during temptation to carry the logs and was hit by the log in his chest, then he was hospitalized due to pectoral pain; during hospitalization decompensated heart".The patient has recovered.No additional relevant information has been received to date.

Event Description

Follow up information was received clarifying the reported events.It was reported that the patient fell during an attempt to carry logs and was hit by a log in his chest, leading to hospitalization on (b)(6) 2019 from pectoral pain.While hospitalized, the patient experienced decompensated heart failure with hypotension which was stated to be likely caused by the excess of iv administered fluids.This led to prolonged hospitalization and the patient was treated with minimal inotropic stimulation of dopamine and further iv therapy.It was noted that the patient transferred hospitals for the maintenance of the hypotension.On the 9th day as reported, the patient was discharged and had the vitaria device titrated (titration was delayed due the hospitalization).The events were reported to be not related to the vitaria implant, stimulation, or system, and was stated to be possibly related to the patient's underlying disease.There were no actions taken with study treatment due to the serious adverse event, and it was noted that the adverse events were resolved.No additional, relevant information was 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8485766
• MDR Text Key: 141009978
• Report Number: 1644487-2019-00657
• Device Sequence Number: 1
• Product Code: MUZ
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2019

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: 03/14/2019
• Device Model Number: 7103
• Device Lot Number: 5962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/10/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 04/11/2019; 08/02/2019
• Supplement Dates FDA Received: 04/24/2019; 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• 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