FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2101018
·
Received May 24, 2011
Report
- Report Number
- 2101018
- Event Type
- Injury
- Date Received
- May 24, 2011
- Report Date
- August 9, 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 FAILURESPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE. ADDITIONAL TEXT: ALARMING WHEN BLACK CORD FROM CONTROLLER IS BENT. SPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION. ADDITIONAL TEXT: ALARMING WITH BLACK CORD FROM CONTROLLER IS BENT. OTHER COMPONENT: CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLER. OTHER INTERVENTION : IMPLANT DEVICE TYPE: LVAD.
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 | 27.1 YR |