Brand Name | POLARSHEATH |
Type of Device | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Manufacturer (Section D) |
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
302 parkway |
global park, la aurora |
heredia |
CS |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
302 parkway, global park |
|
la aurora - heredia |
CS
|
|
Manufacturer Contact |
timothy
degroot
|
4100 hamline avenue north |
dc a330 |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 11604341 |
MDR Text Key | 243546709 |
Report Number | 2134265-2021-04236 |
Device Sequence Number | 1 |
Product Code |
DRA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,study |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/01/2021 |
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 | 07/16/2021 |
Device Model Number | M004CRBSUSC3050 |
Device Lot Number | 0025971563 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/10/2021 |
Initial Date FDA Received | 04/01/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/04/2020 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 68 YR |
Patient Weight | 95 |
|
|