FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2011074
·
Received March 8, 2011
Report
- Report Number
- 2011074
- Event Type
- Injury
- Date Received
- March 8, 2011
- Date of Event
- October 4, 2010
- Report Date
- May 20, 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: EXTERNAL CONTROL SYSTEM FAILUREADDITIONAL TEXT: DISPLAY MODULE NOT WORKINGSPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTIONADDITIONAL TEXT: DISPLAY MODULLEOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: PATIENT NONCOMPLIANCE IN DEVICE MAINTENANCE AND PROTECTION; PATIENT ERROR IN CARING FOR SYSTEMOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLEROTHER INTERVENTION :IMPLANT DEVICE TYPE: BOTH (IN THE SAME OR VISIT)MALFUNCTION DEVICE TYPE: LVAD
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURESPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION
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 | 50.7 YR | RVAD - LEVITRONIX| RVAD - LEVITRONIX |