Brand Name | ZINGER XT |
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 |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 9205471 |
MDR Text Key | 163636480 |
Report Number | 1220452-2019-00136 |
Device Sequence Number | 1 |
Product Code |
DQT
|
UDI-Device Identifier | 00643169452299 |
UDI-Public | 00643169452299 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K983927 |
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 |
10/17/2019 |
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 | 10/24/2021 |
Device Model Number | LVZRXT180J |
Device Catalogue Number | LVZRXT180J |
Device Lot Number | G18A10971 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/26/2019 |
Initial Date FDA Received | 10/17/2019 |
Date Device Manufactured | 10/25/2018 |
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 Age | 71 YR |
|
|