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