Brand Name | HEARTMATE 3 LVAS IMPLANT KIT |
Type of Device | VENTRICULAR (ASSISST) BYPASS |
Manufacturer (Section D) |
THORATEC CORPORATION |
6035 stoneridge drive |
pleasanton CA 94588 |
|
Manufacturer (Section G) |
THORATEC CORPORATION |
6035 stoneridge drive |
|
pleasanton CA 94588 |
|
Manufacturer Contact |
bob
fryc
|
6035 stoneridge drive |
pleasanton, CA 94588
|
7818528204
|
|
MDR Report Key | 11693732 |
MDR Text Key | 246264458 |
Report Number | 2916596-2021-01860 |
Device Sequence Number | 1 |
Product Code |
DSQ
|
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | P160054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
06/17/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/20/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/04/2022 |
Device Model Number | 106524INT |
Device Lot Number | 7651639 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 06/15/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/04/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|