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 Death (1802)

Event Date 07/30/2019

Event Type  Death  

Event Description

It was reported that anthem study patient passed away per physician possibly related to the vitaria stimulation since it occurred during sleep.It was stated that possible cause of death could be sudden arrhythmic death syndrome that may or may not be related to vitaria system.The death is also related to the patient's underlying disease as the patient had severe chronic dilated heart failure that is usually related to sudden cardiac death.No additional relevant information has been received to date.

Event Description

Additional information was received indicating the patient's death was confirmed by ambulance doctor on call.A narrative for the patient was also received in which it was indicated that the patient had a history of chronic dilated ischemic cardiomyopathy, previous myocardial infarction & pci in dec 2017 with an ejection fraction (ef) of 10-15%, and a previous smoker until 2017.The patient's titration history was provided.Impedance in between the initial and last programming were within normal limits with no indication of a device failure.It was indicated that the patient had sudden cardiac death which occurred during their sleep.It was initially reported by the investigator that the possible cause of death could be sudden arrhythmic death syndrome that could be or not related to vitaria system.The independent clinic events committee (cec) adjudicated this event as not device related.The following information was provided in the death certificate: place, time, and date of death: died at home at 03:00 am on july 30, 2019.Direct cause: cardiac arrest.Preceding cause: unspecified jaundice.Underlying cause: cirrhosis of the liver.Other significant conditions, diseases, and injuries that contributed to death: chronic (illegible) cardiomyopathy; history of (illegible) and cardiac pacemaker implantation (vns therapy device).A conclusion was noted in the narrative that based on the patient's past medical history and the events that lead to the subject¿s death, the cec adjudication and the death certificate, there is no reason to believe that the vitaria system caused or contributed to the subject¿s death.

• 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: 8921621
• MDR Text Key: 155232892
• Report Number: 1644487-2019-01627
• 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: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/17/2020
• 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: 07/30/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2018
• 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): Death
• Patient Age: 63 YR
• Patient Weight: 82