FDA Adverse Event
Death
Summary report: N
HEARTMATE II LVAS
MDR report key: 3090747
·
Received May 2, 2013
Report
- Report Number
- 3090747
- Event Type
- Death
- Date Received
- May 2, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 27, 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
CARDIOGENIC SHOCK, POWER SPIKES TO 14, LDH 3400, SUSPECTED PUMP THROMBOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192390 | HEARTMATE II LVAS | LVAD | DSQ | THORATEC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |