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 |