FDA Adverse Event
Other
Summary report: N
THORATEC HEARTMATE XVE LVAD
MDR report key: 571173
·
Received January 24, 2005
Report
- Report Number
- 571173
- Event Type
- Other
- Date Received
- January 24, 2005
- Date of Event
- January 15, 2004
- Report Date
- January 24, 2005
- Manufacturer
- THORATEC LABORATORIES CORP
- Product Code
- DSQ
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
PATIENT WITH PAST HISTORY OF CAD, CORONARY ARTERY DISEASE AND ISCHEMIC CARDIOMYOPATHY, PRESENTED TO THE FACILITY WITH ACUTE MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION REVEALED SEVERE 3 VESSEL DISEASE WITH INCLUSION OF SEVERE LEFT MAIN CORONARY DISEASE AND LEFT VENTRICULAR DYSFUCTION. THE PATIENT HAD IMPLANTATION OF LEFT VENTRICULAR ASSIST DEVICE A FEW DAYS LATER. LESS THAN A WEEK LATER, THE LVAD, LEFT VENTRICULAR ASSIST DEVICE, ALARMED SUDDENLY, THE PATIENT BECAME UNRESPONSIVE WITHIN SECONDS AND RESUSCITATION EFFORTS WERE INITIATED, BUT WERE UNSUCCESSFUL. FOLLOW UP REVEALS: THE ALARM THAT FAILED IS UNKNOWN AT THIS TIME AND IS BEING EVALUATED. IT IS THE BELIEF OF THE SURGEON THAT THE DEVICE HAD AN ACCUTE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THORATEC HEARTMATE XVE LVAD | LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC LABORATORIES CORP | 1270 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |