FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2212285
·
Received August 15, 2011
Report
- Report Number
- 2212285
- Event Type
- Injury
- Date Received
- August 15, 2011
- Date of Event
- July 22, 2011
- Report Date
- March 14, 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 FAILURESPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE. ADDITIONAL TEXT: DRIVELINE SILICONE PULLED AWAY FROM METAL AT DISTAL END. SPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION. ADDITIONAL TEXT: SILICONE PULLED AWAY FROM METAL, NO ALARMS OR MALFUNCTIONS. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. INTERVENTION(S): OTHER INTERVENTIONS, SPECIFY. OTHER INTERVENTION : CLAM SHELL REPAIR. 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 | 29.6 YR |