Brand Name | TACTICATH |
Type of Device | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
5050 nathan lane north |
plymouth MN 55442 |
|
MDR Report Key | 14051916 |
MDR Text Key | 288869173 |
Report Number | 14051916 |
Device Sequence Number | 1 |
Product Code |
OAE
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
04/05/2022 |
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 Model Number | A-TCSE-DF |
Device Catalogue Number | A-TCSE-DF |
Device Lot Number | 8308891 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/05/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 04/08/2022 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/08/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|