Brand Name | DYNAGEN X4 CRT-D |
Type of Device | CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR |
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 | 16247457 |
MDR Text Key | 308180771 |
Report Number | 2124215-2023-03144 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 00802526534904 |
UDI-Public | 00802526534904 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010012/S341 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/30/2023 |
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 |
Lay User/Patient
|
Device Expiration Date | 04/19/2020 |
Device Model Number | G158 |
Device Catalogue Number | G158 |
Device Lot Number | 190747 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/20/2023 |
Initial Date FDA Received | 01/26/2023 |
Supplement Dates Manufacturer Received | 01/30/2023
|
Supplement Dates FDA Received | 01/30/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/04/2018 |
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) |
Required Intervention;
Hospitalization;
|
Patient Age | 88 YR |
Patient Sex | Female |