Brand Name | FUSION COMPACT |
Type of Device | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
MEDTRONIC NAVIGATION, INC |
826 coal creek circle |
louisville CO 80027 |
|
Manufacturer (Section G) |
MEDTRONIC NAVIGATION, INC |
826 coal creek circle |
|
louisville CO 80027 |
|
Manufacturer Contact |
stacy
ruemping
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635260594
|
|
MDR Report Key | 8911842 |
MDR Text Key | 155041749 |
Report Number | 1723170-2019-04560 |
Device Sequence Number | 1 |
Product Code |
PGW
|
Combination Product (y/n) | N |
Reporter Country Code | DA |
PMA/PMN Number | K153247 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/21/2020 |
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 Model Number | 9735602 |
Device Catalogue Number | 9735602 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/22/2019 |
Initial Date Manufacturer Received |
07/26/2019 |
Initial Date FDA Received | 08/20/2019 |
Supplement Dates Manufacturer Received | 04/20/2020
|
Supplement Dates FDA Received | 04/21/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/28/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |