FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2251854
·
Received September 16, 2011
Report
- Report Number
- 2251854
- Event Type
- Injury
- Date Received
- September 16, 2011
- Date of Event
- June 14, 2010
- Report Date
- April 19, 2012
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- Adverse Event
- 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: DRIVE UNIT FAILURESPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: DRIVE UNIT FAILURE.ADDITIONAL TEXT: DRIVE LINE INFECTION.SPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION.ADDITIONAL TEXT: INFECTION/CAUSE FOR REVISION.CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED.OTHER CAUSE:INTERVENTION(S): REPLACEMENT OF DRIVELINE.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 | 47.7 YR |