FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2210830
·
Received August 12, 2011
Report
- Report Number
- 2210830
- Event Type
- Injury
- Date Received
- August 12, 2011
- Date of Event
- October 18, 2010
- Report Date
- March 14, 2012
- 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 THROMBOSISSPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSIS.ADDITIONAL TEXT: SMALL MOBILE MASS OR THROMBUS SEEN ON WIRE OF RIGHT ATRIUM.SPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY.ADDITIONAL TEXT:OTHER COMPONENT: RV PACER LEAD AND INFLOW CANNULA.CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED.OTHER CAUSE:INTERVENTION(S): OTHER INTERVENTIONS, SPECIFY.OTHER INTERVENTION : PACER GENERATOR AND LEAD EXPLANTED.IMPLANT DEVICE TYPE: BOTH (IN THE SAME OR VISIT).MALFUNCTION DEVICE TYPE: LVAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE II LVAS | BIVAD | DSQ | THORATEC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22.6 YR | (B)(4)| (B)(4) |