MAUDE Adverse Event Report: HEARTWARE MEDTRONIC; HEARTWARE LVAD

Device Problems Improper Flow or Infusion (2954); Pumping Problem (3016); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Lactate Dehydrogenase Increased (4567); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/14/2021

Event Type  Injury  

Event Description

A (b)(6) yo w/ pmh hfref (30%) icm s/p heartware 2018, presented with increased ldh and dark urine, elevated powers and vad flows.Pt found to have pump failure for presumed thrombus.Was taken to operating room on 04/14/2021 for pump exchange.

• Brand Name: HEARTWARE MEDTRONIC
• Type of Device: HEARTWARE LVAD
• MDR Report Key: 11783550
• MDR Text Key: 249295671
• Report Number: 11783550
• Device Sequence Number: 1
• Product Code: DSQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/14/2021
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 79