FDA Adverse Event Injury Summary report: N

HEARTMATE II LVAS

MDR report key: 2973014 · Received February 21, 2013

Report

Report Number
2973014
Event Type
Injury
Date Received
February 21, 2013
Date of Event
November 29, 2011
Report Date
February 21, 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 THROMBOSED A SECOND TIME AND WAS EXPLANTED WITHOUT A NEW IMPLANT. PT TOLERATED WELL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
76549 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

Patients

Seq Age Sex Outcome Treatment
1