Brand Name | INQUIRY STEERABLE DIAGNOSTIC CATHETER |
Type of Device | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
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 |
|
MDR Report Key | 12638746 |
MDR Text Key | 276592535 |
Report Number | 3008452825-2021-00489 |
Device Sequence Number | 1 |
Product Code |
DRF
|
UDI-Device Identifier | 05414734306034 |
UDI-Public | 05414734306034 |
Combination Product (y/n) | N |
PMA/PMN Number | K961924 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
10/25/2021 |
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 | 03/31/2024 |
Device Model Number | IBI-81871 |
Device Catalogue Number | IBI-81871 |
Device Lot Number | 7949839 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/15/2021 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/17/2021 |
Initial Date FDA Received | 10/15/2021 |
Supplement Dates Manufacturer Received | 10/25/2021
|
Supplement Dates FDA Received | 10/25/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | INQUIRY CATHETER.; INQUIRY CATHETER. |
|
|