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 11/19/2020

Event Type  Death  

Event Description

Patient passed away due to cardiac arrest.It was noted that the patient was having agonal respirations and was unresponsive, discovered by family.The patient suffered cardiac arrest in ambulance and was defibrillated and provided with epinephrine and amiodarone, and the patient was then pronounced dead at the hospital.No other relevant information has been received to date.

Event Description

Additional information was received that the death was not related to the vitaria device in any way, it was related to underlying cardiac disease.No other 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
• MDR Report Key: 10977136
• MDR Text Key: 220479559
• Report Number: 1644487-2020-01653
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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
• Event Location: Other
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 01/01/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR