Brand Name | ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK OUS) |
Type of Device | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
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 |
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 | 16709998 |
MDR Text Key | 312988305 |
Report Number | 3008452825-2023-00157 |
Device Sequence Number | 1 |
Product Code |
DQK
|
Combination Product (y/n) | N |
Reporter Country Code | PO |
PMA/PMN Number | K202066 |
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 |
06/16/2023 |
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 Expiration Date | 06/30/2024 |
Device Model Number | ENSITE-SEK-5-I-01 |
Device Lot Number | 8820055 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/03/2023 |
Initial Date FDA Received | 04/10/2023 |
Supplement Dates Manufacturer Received | 05/24/2023
|
Supplement Dates FDA Received | 06/16/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/03/2023 |
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 |
|
|