MAUDE Adverse Event Report: MEDTRONIC, INC. HEARTWARE 3; VENTRICULAR (ASSIST) BYPASS

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2020

Event Type  Death  

Event Description

Patient had heartware 3 and pump stopped without sounding alarm.Patient died.Medications and medical devices list will be provided later.Fda safety report id# (b)(4).

• Brand Name: HEARTWARE 3
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 12016394
• MDR Text Key: 257164612
• Report Number: MW5101931
• Device Sequence Number: 1
• Product Code: DSQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 84