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 Arrhythmia (1721)

Event Date 10/30/2019

Event Type  Injury  

Event Description

It was reported via clinical study report that the patient was experiencing arrhythmia with a possible relation to the implant or stimulation.Information was later received indicating that it was not related to the implant.A follow up report revealed that the arrhythmia was possibly related to device stimulation.It was stated that the arrhythmia was bradycardia in which the patient experienced pauses of a duration of 3.1 seconds and ventricular extrasystoles.The patient was examined by a cardiologist and was asymptomatic.The patient was placed on a 24 hour holter monitor and the patient did not have pauses with a duration of more than 2.5 seconds.The maximum pause duration was 1.7 seconds and there was one episode of nsvt (3 extrasystoles in a row).The severity of the event was reported as mild and not serious.The event was reported as resolved.No action was taken with study treatment and a non-drug treatment was required.No additional 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9430392
• MDR Text Key: 169811286
• Report Number: 1644487-2019-02357
• 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
• Report Date: 01/14/2020

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: 07/10/2020
• Device Model Number: 7103
• Device Lot Number: 204594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/31/2019
• Supplement Dates FDA Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2018
• 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): Required Intervention
• Patient Age: 63 YR