FDA Adverse Event
Death
Summary report: N
HEARTMATE II LVAD
MDR report key: 2153037
·
Received June 28, 2011
Report
- Report Number
- 2916596-2011-00265
- Event Type
- Death
- Date Received
- June 28, 2011
- Date of Event
- February 6, 2011
- Report Date
- June 2, 2011
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. 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 (LVAD). IT WAS REPORTED BY THE HOSPITAL VAD SUPPORT PERSONNEL THAT THE PT EXPIRED NINE DAYS POST OP. NO OTHER INFO IS KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE II LVAD | LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC CORPORATION | 103695 | 101152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death |