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 | 12297863 |
MDR Text Key | 265772360 |
Report Number | 2916596-2021-04240 |
Device Sequence Number | 1 |
Product Code |
DSQ
|
UDI-Device Identifier | 00813024013297 |
UDI-Public | 00813024013297 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P160054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/11/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 11/19/2022 |
Device Model Number | 106524US |
Device Catalogue Number | 106524US |
Device Lot Number | 7840834 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/13/2021 |
Initial Date FDA Received | 08/09/2021 |
Supplement Dates Manufacturer Received | 09/28/2021
|
Supplement Dates FDA Received | 10/11/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/11/2021 |
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) |
Hospitalization;
Life Threatening;
|
Patient Age | 74 YR |
Patient Weight | 93 |