Brand Name | INVIVE |
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 |
|
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 | 11136397 |
MDR Text Key | 225728583 |
Report Number | 2124215-2021-00247 |
Device Sequence Number | 1 |
Product Code |
NKE
|
UDI-Device Identifier | 00802526536632 |
UDI-Public | 00802526536632 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P030005/S079 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/07/2022 |
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 | 06/11/2016 |
Device Model Number | V173 |
Device Catalogue Number | V173 |
Device Lot Number | 106657 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/15/2021 |
Initial Date Manufacturer Received |
11/27/2020 |
Initial Date FDA Received | 01/07/2021 |
Supplement Dates Manufacturer Received | 11/17/2021
|
Supplement Dates FDA Received | 01/07/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/29/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-2016-2021 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 83 YR |
Patient Sex | Female |