MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC MCS; HVAD HEARTWARE

Model Number HW32467

Device Problems Energy Output Problem (1431); Unexpected Therapeutic Results (1631); Pumping Problem (3016)

Patient Problems Low Blood Pressure/ Hypotension (1914); Renal Impairment (4499)

Event Date 02/17/2022

Event Type  Injury  

Event Description

Patient experienced unexplained high power and low flow on pump without any clear physiological explanation, so therefore was listed for heart transplant.Pump was implanted at osh in 2018.A 49 years old male with dilated cmy s/p lvad in 2018, dli with mssa on chronic antibiotic therapy.Diabetes who is now transferred from rgb with concern initially for pump thrombosis which was ruled out was later discharged and had a low flow on pump without any clear physiological explanation which also caused hypotension and aki episode.Given no clear explanation of these events so therefore decision was made to list for heart transplantation as unos status 2 for device malfunction.

• Brand Name: MEDTRONIC MCS
• Type of Device: HVAD HEARTWARE
• Manufacturer (Section D): MEDTRONIC; miami lakes FL 33014
• MDR Report Key: 14955240
• MDR Text Key: 295487636
• Report Number: 14955240
• 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: User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: HW32467
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/17/2022
• Event Location: Hospital
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 86 KG