Brand Name | AMPLATZER SEPTAL OCCLUDER |
Type of Device | TRANSCATHETER SEPTAL OCCLUDER |
Manufacturer (Section D) |
ABBOTT MEDICAL |
5050 nathan lane n |
plymouth MN 55442 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL #3014918977 |
edificio #44 calle 0, ave. 2 |
|
el coyol alajuela 1897- 4050 |
CS
1897-4050
|
|
Manufacturer Contact |
karen
krouse
|
5050 nathan lane n |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 18322763 |
MDR Text Key | 330430899 |
Report Number | 2135147-2023-05495 |
Device Sequence Number | 1 |
Product Code |
MLV
|
UDI-Device Identifier | 00811806010199 |
UDI-Public | 00811806010199 |
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | P000039 |
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 |
02/14/2024 |
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 |
Health Professional
|
Device Catalogue Number | 9-ASD-024 |
Device Lot Number | 8845446 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/13/2023 |
Supplement Dates Manufacturer Received | 02/12/2024
|
Supplement Dates FDA Received | 02/14/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/17/2023 |
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 |