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 |
glen
belmer
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
6122713209
|
|
MDR Report Key | 13284819 |
MDR Text Key | 292064885 |
Report Number | 1723170-2022-00072 |
Device Sequence Number | 1 |
Product Code |
PGW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153247 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/18/2022 |
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? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/28/2021 |
Initial Date FDA Received | 01/18/2022 |
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 |
Patient Age | 20 YR |
Patient Sex | Female |
Patient Weight | 44 KG |
|
|