Brand Name | ZINGER GUIDE WIRE - CRDM |
Type of Device | OCCLUDER, CATHETER TIP |
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 |
lisa
robertson
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635262723
|
|
MDR Report Key | 7491116 |
MDR Text Key | 107503966 |
Report Number | 1220452-2018-00045 |
Device Sequence Number | 1 |
Product Code |
DQT
|
UDI-Device Identifier | 20643169452293 |
UDI-Public | 20643169452293 |
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | K983927 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/19/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/13/2020 |
Device Model Number | LVZRXT180J |
Device Catalogue Number | LVZRXT180J |
Device Lot Number | G17A06502 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/05/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/10/2018 |
Initial Date FDA Received | 05/07/2018 |
Supplement Dates Manufacturer Received | 02/27/2019
|
Supplement Dates FDA Received | 03/19/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/14/2017 |
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 |
|
|