FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2073634
·
Received May 2, 2011
Report
- Report Number
- 2073634
- Event Type
- Injury
- Date Received
- May 2, 2011
- Date of Event
- April 22, 2011
- Report Date
- August 16, 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: SEVERE HEMATURIASPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTIONADDITIONAL TEXT: POSSIBLE PUMP THROMBUSOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: PATIENT NONCOMPLIANCE IN DEVICE MAINTENANCE AND PROTECTION; PATIENT ERROR IN CARING FOR SYSTEMOTHER CAUSE:INTERVENTION(S): OTHER INTERVENTIONS, SPECIFYOTHER INTERVENTION : IV HEPARIN - ANTICOAGULATION THERAPYIMPLANT DEVICE TYPE: LVADMALFUNCTION DEVICE TYPE:
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSISSPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION
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 | 16.4 YR |