Brand Name | WATCHMAN ACCESS SYSTEM |
Type of Device | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
ballybrit business park |
|
galway |
EI
|
|
Manufacturer Contact |
rachel
shields
|
4100 hamline ave n |
arden hills, MN 55112
|
6512422111
|
|
MDR Report Key | 17219061 |
MDR Text Key | 318070181 |
Report Number | 2124215-2023-32084 |
Device Sequence Number | 1 |
Product Code |
NGV
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/28/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/28/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 10374 |
Device Catalogue Number | 10374 |
Device Lot Number | 0030133342 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/14/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/12/2022 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 68 YR |
Patient Sex | Male |
Patient Weight | 74 KG |
|
|