Brand Name | AMPLATZER SEPTAL OCCLUDER |
Type of Device | CARDIAC OCCLUSION DEVICE |
Manufacturer (Section D) |
AGA MEDICAL CORPORATION |
5050 nathan lane north |
plymouth MN 55442 |
|
Manufacturer (Section G) |
AGA MEDICAL CORPORATION |
5050 nathan lane north |
|
plymouth MN 55442 |
|
Manufacturer Contact |
denise
johnson
|
5050 nathan lane north |
plymouth, MN 55442
|
6517564470
|
|
MDR Report Key | 3660856 |
MDR Text Key | 4283962 |
Report Number | 2135147-2014-00022 |
Device Sequence Number | 1 |
Product Code |
MLV
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P000039 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/26/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/05/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 10/16/2014 |
Device Model Number | 9-ASD-030 |
Device Catalogue Number | 9-ASD-030 |
Device Lot Number | 0910165902 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/26/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/16/2009 |
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;
|
Patient Age | 38 YR |