FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2190716
·
Received August 4, 2011
Report
- Report Number
- 2190716
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- November 20, 2010
- Report Date
- October 18, 2011
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSISADDITIONAL TEXT: THROMBUS IN APICAL CONDUIT, AND OUTFLOW GRAFTSPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFYADDITIONAL TEXT:OTHER COMPONENT: PUMP THROMBUSCAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF PUMPOTHER INTERVENTION :IMPLANT DEVICE TYPE: LVADMALFUNCTION DEVICE TYPE:
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSIS. SPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE II LVAS | LVAD | DSQ | THORATEC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41.1 YR |