FDA Adverse Event
Injury
Summary report: N
HEARTWARE HVAD
MDR report key: 3183090
·
Received June 21, 2013
Report
- Report Number
- 3183090
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 12, 2013
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DISPLAY ON HIS CONTROLLER WENT OUT. BROUGHT TO HOSPITAL TO EXCHANGE CONTROLLER PER LVAD COORDINATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282662 | HEARTWARE HVAD | LVAD | DSQ | HEARTWARE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |