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 |