FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 1904742
·
Received November 22, 2010
Report
- Report Number
- 1904742
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- December 24, 2009
- Report Date
- April 19, 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 FAILURE.SPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION.
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILUREADDITIONAL TEXT: BROKEN CONTROLLER CLIPSPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTIONADDITIONAL TEXT: BROKEN CONTROLLER CLIPOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLEROTHER INTERVENTION :IMPLANT DEVICE TYPE: LVADMALFUNCTION DEVICE TYPE:
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 | 65.4 YR |