FDA Adverse Event
Death
Summary report: N
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
MDR report key: 2431793
·
Received January 24, 2012
Report
- Report Number
- 2916596-2012-00014
- Event Type
- Death
- Date Received
- January 24, 2012
- Date of Event
- December 20, 2011
- Report Date
- December 28, 2011
- Manufacturer
- THORATEC CORP.
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. THE PERFUSIONIST REPORTED THAT THE PT EXPERIENCED A HEMORRHAGIC STROKE AND RESPIRATORY COMPROMISE. LIFE SUPPORT WAS WITHDRAWN AT THE FAMILY'S REQUEST.
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. | 104911 | 107661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death |