FDA Adverse Event Death Summary report: N

HEARTMATE II LVAS

MDR report key: 3090747 · Received May 2, 2013

Report

Report Number
3090747
Event Type
Death
Date Received
May 2, 2013
Date of Event
April 15, 2013
Report Date
April 27, 2013
Manufacturer
THORATEC CORPORATION
Product Code
DSQ
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
AL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

CARDIOGENIC SHOCK, POWER SPIKES TO 14, LDH 3400, SUSPECTED PUMP THROMBOSIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
192390 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 Death