FDA Adverse Event
Death
Summary report: N
HEARTMATE II LVAD
MDR report key: 3053344
·
Received April 11, 2013
Report
- Report Number
- 3053344
- Event Type
- Death
- Date Received
- April 11, 2013
- Date of Event
- February 16, 2013
- Report Date
- April 10, 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
LVAD PUMP CLOTTED OFF. NOTHING WAS DONE AS IT WAS REQUESTED BY PATIENT FAMILY TO HAVE COMFORT CARE AND HOSPICE CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156418 | HEARTMATE II LVAD | LVAS | DSQ | THORATEC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |