FDA Adverse Event
Death
Summary report: N
HEARTMATE II LVAS
MDR report key: 1714602
·
Received June 8, 2010
Report
- Report Number
- 2916596-2010-00134
- Event Type
- Death
- Date Received
- June 8, 2010
- Date of Event
- May 9, 2010
- Report Date
- May 11, 2010
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE CIRCULATORY RESEARCH COORDINATOR REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY TWO-AND-A-HALF WEEKS POST IMPLANTATION OF THE LVAD. THE HOSPITAL SUSPECTED THROMBUS IN THE DEVICE. THERE WERE NO ALARMS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE II LVAS | LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC CORPORATION | 103695 | 89493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Death |