Brand Name | MICRA |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
MEDTRONIC, INC. |
8200 coral sea street |
mounds view MN 55112 |
|
Manufacturer (Section G) |
MEDTRONIC, INC. |
8200 coral sea street |
|
mounds view MN 55112 |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 6779862 |
MDR Text Key | 82363970 |
Report Number | 2182208-2017-01099 |
Device Sequence Number | 1 |
Product Code |
DYB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132030 |
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 |
04/10/2018 |
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 Model Number | MI2355A |
Device Catalogue Number | MI2355A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/05/2017 |
Initial Date FDA Received | 08/09/2017 |
Supplement Dates Manufacturer Received | 02/02/2018
|
Supplement Dates FDA Received | 04/10/2018
|
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 Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 80 YR |
Patient Weight | 85 |
|
|