MAUDE Adverse Event Report: MEDTRONIC-HEARTWARE MEDTRONIC HEARTWARE LVAD

Model Number 1404

Device Problems Detachment Of Device Component (1104); Separation Failure (2547); Device Displays Incorrect Message (2591)

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

Event Date 06/26/2017

Event Type  malfunction  

Event Description

Received call from patient that his heartware lvad controller was alarming electrical fault, ensure power connections to controller were secure and controller was running was evidenced by display on controller of flow 6.5 liters; speed: 2900 rpm; power: 7.2 watts; spoke with mom and requested controller to be exchanged.Ems was summoned to home for safety, mom successfully exchanged controller, ensured lvad was functioning/running, however mom was unable to disconnect battery from controller, she pulled on battery as she was anxious and connection port pulled off of disconnected from controller, reviewed again with mom safety with controller, power connections and warned against forceful power disconnections from controller.

• Brand Name: MEDTRONIC HEARTWARE LVAD
• Type of Device: HEARTWARE
• Manufacturer (Section D): MEDTRONIC-HEARTWARE; miami FL 33301 4
• MDR Report Key: 6680494
• MDR Text Key: 78955522
• Report Number: MW5070733
• 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: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1404
• Device Lot Number: 1404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• 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 Age: 20 YR
• Patient Weight: 150