FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2251843
·
Received September 16, 2011
Report
- Report Number
- 2251843
- Event Type
- Injury
- Date Received
- September 16, 2011
- Date of Event
- August 9, 2011
- Report Date
- April 19, 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: EXTERNAL CONTROL SYSTEM FAILURE. ADDITIONAL TEXT: SYSTEM CONTROLLER. SPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION. ADDITIONAL TEXT: WHITE CABLE ON ORIGINAL CONTROLLER HOT AND SMOKING; BACK UP WENT INTO BACK UP MODE WHEN SWITCHED OUT. OTHER COMPONENT: CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLED OTHER INTERVENTION : IMPLANT 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 | LVAD | DSQ | THORATEC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54.3 YR |