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 Cardiac Arrest (1762)

Event Date 03/15/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced vt/vf arrest, and the relationship to the vitaria device is unknown.No additional relevant information has been received to date.

Event Description

Additional information was received that the vt/vf arrest is not related to device, surgery or system.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14112046
• MDR Text Key: 289268600
• Report Number: 1644487-2022-00439
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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 Model Number: 7103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/28/2022
• 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