MAUDE Adverse Event Report: MEDTRONIC/HEARTWARE HVAD HEARTWARE 3 LEFT VENTRICULAR ASSIST DEVICE; VENTRICULAR (ASSIST) BYPASS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2018

Event Type  malfunction  

Event Description

Exchanged heartware 3 lvad based on suspicion of malfunction.Awaiting analysis and report from company.

• Brand Name: HVAD HEARTWARE 3 LEFT VENTRICULAR ASSIST DEVICE
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC/HEARTWARE; miami lakes FL 33014
• MDR Report Key: 7637770
• MDR Text Key: 112460798
• Report Number: MW5078049
• 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
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 122