HEARTWARE MEDTRONIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for HEARTWARE MEDTRONIC manufactured by Heartware Medtronic.

Event Text Entries

[141373652] Pt was at cardiac rehab when his driveline became disconnected from heartware lvad. He was in changing room when this happened. Vad team contacted, and on phone with wife, however staff / wife on scene unable to reconnect driveliine. Pt suffered cardiac arrest, vad was unable to be reconnected by ed/ ems staff. Pt was transferred to (b)(6) hospital after being resuscitated. He expired after care withdrawn by family.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8496070
• MDR Report Key: 8496070
• Date Received: 2019-04-03
• Date of Report: 2019-03-27
• Date of Event: 2019-02-18
• Date Facility Aware: 2019-02-18
• Report Date: 2019-03-27
• Date Reported to FDA: 2019-04-03
• Date Added to Maude: 2019-04-09
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: HEARTWARE MEDTRONIC
• Generic Name: HEARTWARE
• Product Code: DSQ
• Date Received: 2019-04-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: HEARTWARE MEDTRONIC
• Manufacturer Address: 500 OLD CONNECTICUT PATH RD FRAMINGHAM MA 01701 US 01701

Device Sequence Number: 1

• Brand Name: HEARTWARE MEDTRONIC
• Generic Name: HEARTWARE
• Product Code: OKR
• Date Received: 2019-04-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HEARTWARE MEDTRONIC
• Manufacturer Address: 500 OLD CONNECTICUT PATH RD FRAMINGHAM MA 01701 US 01701

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Deathisabilit	2019-04-03