Brand Name | ADVANCE |
Type of Device | CATHETER, EMBOLECTOMY |
Manufacturer (Section D) |
MEDTRONIC, INC |
37a cherry hill dr |
danvers MA 01923 |
|
Manufacturer (Section G) |
MEDTRONIC, INC |
37a cherry hill dr |
|
danvers MA 01923 |
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
091708734
|
|
MDR Report Key | 8973863 |
MDR Text Key | 156884211 |
Report Number | 1220452-2019-00113 |
Device Sequence Number | 1 |
Product Code |
DXE
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K152335 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/09/2019 |
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 |
Health Professional
|
Device Catalogue Number | UNK-CV-DAN-EXP-ADV |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/16/2019
|
Initial Date FDA Received | 09/09/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|