FDA Adverse Event
Death
Summary report: N
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
MDR report key: 3001184
·
Received March 8, 2013
Report
- Report Number
- 2916596-2013-00239
- Event Type
- Death
- Date Received
- March 8, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 8, 2013
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PT EXPIRED AND THE PUMP WAS NOT EXPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE HOSPITAL REPORTED THAT THE PT EXPIRED IN THE HOSPITAL. RAMP SPEED STUDIES SHOWED POOR FLOW THROUGH THE PUMP. THE PT SUFFERED A LARGE POSTERIOR BLEED TO THE BRAIN AND CARE WAS WITHDRAWN THE NEXT DAY. THE PUMP WAS NOT RECOVERED FROM THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99330 | HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE | DSQ: LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC CORPORATION | 104911 | 116896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Death |