Brand Name | INCEPTA ICD |
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 | 10618050 |
MDR Text Key | 209553982 |
Report Number | 2124215-2020-15614 |
Device Sequence Number | 1 |
Product Code |
LWP
|
UDI-Device Identifier | 00802526480775 |
UDI-Public | 00802526480775 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | P960040/S235 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/01/2020 |
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 | 04/03/2015 |
Device Model Number | E162 |
Device Catalogue Number | E162 |
Device Lot Number | 106246 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/20/2020 |
Initial Date FDA Received | 10/01/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/08/2013 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 41 YR |