Brand Name | MICRA |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
MEDTRONIC IRELAND |
parkmore business park west |
galway,ie |
|
Manufacturer (Section G) |
MEDTRONIC IRELAND |
parkmore business park west |
|
galway,ie |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 8634241 |
MDR Text Key | 145897103 |
Report Number | 9612164-2019-01900 |
Device Sequence Number | 1 |
Product Code |
DYB
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K132030 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,s |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
06/27/2019 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/06/2020 |
Device Model Number | MI2355A |
Device Catalogue Number | MI2355A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/26/2019 |
Initial Date FDA Received | 05/22/2019 |
Supplement Dates Manufacturer Received | 05/24/2019 06/26/2019
|
Supplement Dates FDA Received | 05/24/2019 06/27/2019
|
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) |
Other;
|
Patient Age | 69 YR |
Patient Weight | 113 |
|
|