Brand Name | EMBLEM MRI S-ICD |
Type of Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 | 11182265 |
MDR Text Key | 227501091 |
Report Number | 2124215-2021-00633 |
Device Sequence Number | 1 |
Product Code |
LWS
|
UDI-Device Identifier | 00802526584404 |
UDI-Public | 00802526584404 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P110042/S058 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/15/2021 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 05/10/2019 |
Device Model Number | A219 |
Device Catalogue Number | A219 |
Device Lot Number | 210473 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/30/2020 |
Initial Date FDA Received | 01/15/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/22/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
|
Patient Age | 48 YR |