FDA Adverse Event Injury Summary report: N

HEARTMATE II LVAS

MDR report key: 2933794 · Received January 29, 2013

Report

Report Number
2933794
Event Type
Injury
Date Received
January 29, 2013
Date of Event
January 5, 2013
Report Date
January 29, 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

PATIENT NOTED AN ISSUE WITH THE DM READING "NOT CONNECTED". NO NEWALARMS, SYMPTOMS OR DAMAGE TO DM/PM/CABLES.ALL EFFECTED EQUIPMENT CHANGED OUT. NO FURTHER ISSUES TO DATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
38789 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

Patients

Seq Age Sex Outcome Treatment
1