Brand Name | VALITUDE X4 CRT-P |
Type of Device | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
4100 hamline avenue north |
saint paul MN 55112 |
|
MDR Report Key | 8504353 |
MDR Text Key | 141613894 |
Report Number | 2124215-2019-03331 |
Device Sequence Number | 1 |
Product Code |
NKE
|
UDI-Device Identifier | 00802526559402 |
UDI-Public | 00802526559402 |
Combination Product (y/n) | N |
PMA/PMN Number | P030005/S113 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup,Followup |
Report Date |
04/07/2021 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 01/31/2019 |
Device Model Number | U128 |
Device Catalogue Number | U128 |
Device Lot Number | 717487 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/03/2019 |
Initial Date FDA Received | 04/11/2019 |
Supplement Dates Manufacturer Received | 06/12/2019 01/27/2021
|
Supplement Dates FDA Received | 06/21/2019 04/07/2021
|
Patient Sequence Number | 1 |
Patient Age | 73 YR |
|
|