FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2190668
·
Received August 4, 2011
Report
- Report Number
- 2190668
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- July 21, 2011
- Report Date
- February 24, 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: DRIVE UNIT FAILURE. SPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION.
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: DRIVE UNIT FAILURE. ADDITIONAL TEXT: DRIVELINE WIRING ISSUE LEADING TO SEVERAL RED HEART ALARMS/ PUMP STOPS; NO FRACTURE NOTED. SPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION. ADDITIONAL TEXT: DRIVELINE WIRING APPEARS TO HAVE POTENTIAL SHORT; NO FRACTURE NOTED. OTHER COMPONENT: CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): OTHER INTERVENTIONS, SPECIFY. OTHER INTERVENTION : UNGROUNDED POWER MODULE CABLE PROVIDED. 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 | 33.2 YR |