MAUDE Adverse Event Report: MEDTRONIC HEARTWARE MEDTRONIC; MEARTWARE LVAD

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Lactate Dehydrogenase Increased (4567)

Event Date 10/20/2021

Event Type  Injury  

Event Description

Patient admitted to hospital with elevated loh and dark urine, ldh cont to uptrend with hf symptoms, pt taken for heartware: hm3 pump exchange, tolerated well.Post op course uncomplicated.

• Brand Name: HEARTWARE MEDTRONIC
• Type of Device: MEARTWARE LVAD
• Manufacturer (Section D): MEDTRONIC; 500 old connecticut path rd; framingham MA
• MDR Report Key: 13228550
• MDR Text Key: 283676262
• Report Number: 13228550
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Race: Black Or African American