Brand Name | ESSENTIO MRI DR |
Type of Device | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
4100 hamline avenue north |
saint paul MN 55112 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
cashel road |
|
clonmel |
EI
|
|
Manufacturer Contact |
timothy
degroot
|
4100 hamline avenue north |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 18687046 |
MDR Text Key | 335145328 |
Report Number | 2124215-2024-08026 |
Device Sequence Number | 1 |
Product Code |
LWP
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P150012/S000 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/12/2024 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 05/05/2023 |
Device Model Number | L111 |
Device Catalogue Number | L111 |
Device Lot Number | 553766 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/29/2024
|
Initial Date FDA Received | 02/12/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/17/2021 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |