MAUDE Adverse Event Report: MEDTRONIC INC. MEDTRONIC HEARTWARE HVAD; VENTRICULAR (ASSIST) BYPASS

Model Number HEARTWARE

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem Cardiac Arrest (1762)

Event Date 02/07/2022

Event Type  Death  

Event Description

Patient suffered out of hospital cardiac arrest secondary to presumed heartware pump failure, log files retrieved from controller indicated patient was connected to 2 batteries with voltage error codes, causing power cycling and ultimately leading to pump stoppage.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC HEARTWARE HVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 13733825
• MDR Text Key: 287111504
• Report Number: MW5108023
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEARTWARE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 166 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American