FDA Adverse Event Injury Summary report: N

HEARTMATE II LVAS

MDR report key: 2810371 · Received October 31, 2012

Report

Report Number
2810371
Event Type
Injury
Date Received
October 31, 2012
Date of Event
October 22, 2012
Report Date
October 31, 2012
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

PATIENT ADMITTED WITH HIGH PUMP POWER AND LOW PI CT ANGIO REVEALED THROMBOSED OUTFLOW GRAFT DEVICE WAS ELECTIVELY

Devices

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

Patients

Seq Age Sex Outcome Treatment
1