FDA Adverse Event Injury Summary report: N

HEARTMATE II LVAS

MDR report key: 3073229 · Received April 23, 2013

Report

Report Number
3073229
Event Type
Injury
Date Received
April 23, 2013
Date of Event
March 4, 2013
Report Date
April 17, 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

PUMP THROMBUS, INTRACARDAIC TPA ATTEMPTED WITHOUT RESOLUTION. ULTIMATELY TRANSPLANTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
173738 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

Patients

Seq Age Sex Outcome Treatment
1