Brand Name | CARTO 3 SYSTEM |
Type of Device | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Manufacturer (Section D) |
|
MDR Report Key | 17077781 |
MDR Text Key | 316756114 |
Report Number | MW5118186 |
Device Sequence Number | 1 |
Product Code |
DQK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
06/05/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/06/2023 |
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
|
Patient Sequence Number | 1 |
Treatment | THERMOCOOL SMARTTOUCH SF ABLATION CATHETER, INTRACARDIAC ECHO, DOPAMINE, EPINEPHRINE, PROTAMINE SULFATE, XARELTO. |
Patient Outcome(s) |
Life Threatening;
Disability;
Hospitalization;
|
Patient Age | 78 YR |
Patient Sex | Female |
Patient Weight | 81 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|