FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2192108
·
Received August 4, 2011
Report
- Report Number
- 2192108
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- July 15, 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: EXTERNAL CONTROL SYSTEM FAILURE.ADDITIONAL TEXT: CONNECTING TO POWER MODULE PRODUCED AUDIBLE ALARM WITH MOVEMENT OF WHITE CONTROLLER LEAD.SPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION.ADDITIONAL TEXT: FRACTURE OF WHITE SYSTEM CONTROLLER LEAD.OTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: PATIENT ERROR IN CARING FOR SYSTEM.OTHER CAUSE:INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLER.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 | 77.2 YR |