Brand Name | TRANSSEPTAL NEEDLE, BRK SERIES |
Type of Device | TROCAR |
Manufacturer (Section D) |
ST. JUDE MEDICAL |
parque industrial, zona franca coyol s.a. |
edificio #44b, calle 0, avenida 2, coyol |
alajuela, costa rica 1897- 4050 |
CS 1897-4050 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, COSTA RICA LTDA (AFD) |
parque industrial, zona franca coyol s.a. |
edificio #44b, calle 0, avenida 2, coyol |
alajuela, costa rica 1897- 4050 |
CS
1897-4050
|
|
Manufacturer Contact |
janna
parks
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 18844764 |
MDR Text Key | 336963864 |
Report Number | 3008452825-2024-00122 |
Device Sequence Number | 1 |
Product Code |
DRC
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
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,Followup |
Report Date |
04/23/2024 |
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 |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/28/2024 |
Initial Date FDA Received | 03/06/2024 |
Supplement Dates Manufacturer Received | 03/08/2024 04/17/2024
|
Supplement Dates FDA Received | 03/08/2024 04/23/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
Other;
|
|
|