Brand Name | ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT |
Type of Device | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Manufacturer (Section D) |
ST. JUDE MEDICAL, COSTA RICA LTDA |
parque industrial, zona franca coyol s.a. |
edificio #44b, calle 0, avenida 2, coyol |
alajuela, costa rica 1897- 4050 |
CS 1897-4050 |
|
MDR Report Key | 8926520 |
MDR Text Key | 155409275 |
Report Number | 3008452825-2019-00430 |
Device Sequence Number | 1 |
Product Code |
DQK
|
UDI-Device Identifier | 05415067025937 |
UDI-Public | 05415067025937 |
Combination Product (y/n) | N |
PMA/PMN Number | K160210 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
09/17/2019 |
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
|
Device Expiration Date | 10/31/2019 |
Device Model Number | EN0020-P |
Device Lot Number | 7019485 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/21/2019 |
Initial Date FDA Received | 08/23/2019 |
Supplement Dates Manufacturer Received | 08/27/2019
|
Supplement Dates FDA Received | 09/17/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|