Brand Name | HEARTWARE® VENTRICULAR ASSIST SYSTEM |
Type of Device | CIRCULATORY ASSIST SYSTEM |
Manufacturer (Section D) |
HEARTWARE, INC. |
14400 nw 60 avenue |
miami lakes FL 33014 3105 |
|
Manufacturer (Section G) |
HEARTWARE, INC. |
14400 nw 60 avenue |
|
miami lakes FL 33014 3105 |
|
Manufacturer Contact |
nathalie
nunez
|
14400 nw 60 avenue |
miami lakes, FL 33014-3105
|
3053641538
|
|
MDR Report Key | 5393690 |
MDR Text Key | 36954718 |
Report Number | 3007042319-2016-00453 |
Device Sequence Number | 1 |
Product Code |
DSQ
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P100047 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/06/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 01/31/2016 |
Device Catalogue Number | 1407DE |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/23/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/06/2016
|
Initial Date FDA Received | 01/27/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/28/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 34 YR |
Patient Weight | 81 |