FDA Adverse Event
Death
Summary report: N
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
MDR report key: 2133358
·
Received June 15, 2011
Report
- Report Number
- 2916596-2011-00245
- Event Type
- Death
- Date Received
- June 15, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 24, 2011
- Manufacturer
- THORATEC CORP.
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE 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. THE PATIENT EXPERIENCED HEMATURIA AND HEMOLYSIS. THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE | LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC CORP. | 103695 | 99296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Death |