Brand Name | REGENT HEART VALVE |
Type of Device | HEART-VALVE, MECHANICAL |
Manufacturer (Section D) |
ABBOTT MEDICAL |
5050 nathan lane n |
plymouth MN 55442 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612 |
20 b st caguas west park |
|
caguas 00725 |
*
00725
|
|
Manufacturer Contact |
karen
krouse
|
5050 nathan lane n |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 17200087 |
MDR Text Key | 317848175 |
Report Number | 2135147-2023-02750 |
Device Sequence Number | 1 |
Product Code |
LWQ
|
UDI-Device Identifier | 05414734005869 |
UDI-Public | 05414734005869 |
Combination Product (y/n) | N |
Reporter Country Code | RS |
PMA/PMN Number | P810002 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
08/03/2023 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 19AGN-751 |
Device Catalogue Number | 19AGN-751 |
Device Lot Number | C00006317 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/31/2023
|
Initial Date FDA Received | 06/26/2023 |
Supplement Dates Manufacturer Received | 07/31/2023
|
Supplement Dates FDA Received | 08/03/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/21/2022 |
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;
|
Patient Sex | Female |
|
|