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 01/26/2020

Event Type  Death  

Event Description

It was reported that an (b)(6) clinical trial patient experienced sudden cardiac death.The event was assessed as possibly related to vittaria implant as sudden cardiac death could be due to a fatal arrhythmia.It was also noted that the event was probably related to the patient's underlying condition as the patient is implanted with vns for heart failure.No additional relevant information has been received to date.

Event Description

Additional information was received indicating that the immediate cause of death was "cardiorespiratory insufficiency." the death report also included note of the patient's relevant significant conditions, including ischemic cardiomyopathy, heart failure, and arterial hypertension.Device history record was reviewed for both the generator and the lead, and no unresolved non-conformances were found.The devices passed all quality control measures prior to distribution.The most recent settings and diagnostics available prior to the date of death were from the 12 month follow up visit and showed no issues with the vns.No additional relevant information has been received to date.

Manufacturer Narrative

Report source, corrected data: initial report inadvertently did not select ¿foreign¿ for report source.

Event Description

Information was received from the clinical study reconciliation report indicating that no autopsy was performed following the patient's death, indicating that the device is not accessible for testing.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: 9745075
• MDR Text Key: 180558403
• Report Number: 1644487-2020-00315
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

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: 07/10/2020
• Device Model Number: 7103
• Device Lot Number: 204594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 03/02/2020; 04/06/2020
• Supplement Dates FDA Received: 03/27/2020; 04/29/2020
• 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): Death