Brand Name | ATTAIN SELECT II |
Type of Device | CATHETER, PERCUTANEOUS |
Manufacturer (Section D) |
MEDTRONIC IRELAND |
parkmore business park west |
galway |
|
Manufacturer (Section G) |
MEDTRONIC IRELAND |
parkmore business park west |
|
galway |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 7766986 |
MDR Text Key | 116864460 |
Report Number | 9612164-2018-02000 |
Device Sequence Number | 1 |
Product Code |
DQY
|
UDI-Device Identifier | 00643169143210 |
UDI-Public | 00643169143210 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123153 |
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,Followup |
Report Date |
10/04/2018 |
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 | 11/22/2019 |
Device Model Number | 6248V-90 |
Device Catalogue Number | 6248V-90 |
Device Lot Number | 0008890931 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/11/2018 |
Initial Date FDA Received | 08/09/2018 |
Supplement Dates Manufacturer Received | 08/08/2018
|
Supplement Dates FDA Received | 10/04/2018
|
Date Device Manufactured | 11/22/2017 |
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 |
Patient Age | 77 YR |
|
|