FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 3051265
·
Received April 10, 2013
Report
- Report Number
- 3051265
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- March 18, 2013
- Report Date
- April 4, 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
INTERMITTENT OCCLUSION OF LVAD INFLOW CANNULA AGAINST SEPTUM NOTED ONECHOCARDIOGRAM;
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148427 | HEARTMATE II LVAS | LVAD | DSQ | THORATEC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |