FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2032880
·
Received March 29, 2011
Report
- Report Number
- 2032880
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- February 1, 2011
- Report Date
- June 7, 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: DRIVELINE MALFUNCTION
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILUREADDITIONAL TEXT: DRIVELINESPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTIONADDITIONAL TEXT: XRAY SENT TO THORATEC REVEALED INTERNAL KINK IN DRIVELINE LIKELY KINKING GROUNDWIREOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLER; OTHER INTERVENTIONS, SPECIFYOTHER INTERVENTION : NON GROUNDED PATIENT CABLE AS RECOMMENDED AND PROVIDED BY THORATECIMPLANT DEVICE TYPE: BOTH (IN THE SAME OR VISIT)MALFUNCTION DEVICE TYPE: LVAD
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE II LVAS | BIVAD | DSQ | THORATEC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57.7 YR | TANDEMHEART - RVAD| TANDEMHEART - RVAD |