Brand Name | VISIONIST CRT-P |
Type of Device | IMPLANTABLE DEVICE |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
4100 hamline avenue north |
saint paul MN 55112 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CLONMEL LIMITED |
cashel road |
, |
clonmel |
EI
|
|
Manufacturer Contact |
timothy
degroot
|
4100 hamline avenue north |
, |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 8722880 |
MDR Text Key | 148793035 |
Report Number | 2124215-2019-10474 |
Device Sequence Number | 1 |
Product Code |
NKE
|
UDI-Device Identifier | 00802526559457 |
UDI-Public | 00802526559457 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P030005/S138 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
10/17/2019 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 06/21/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 04/23/2020 |
Device Model Number | U226 |
Device Catalogue Number | U226 |
Device Lot Number | 700791 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/07/2019 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 07/17/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/10/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
Initial
|
|
|