Brand Name | FUSION NAVIGATION SYSTEM |
Type of Device | NEUROLOGICAL STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
MEDTRONIC NAVIGATION, INC. (LOUISVILLE) |
826 coal creek circle |
louisville CO 80027 |
|
Manufacturer (Section G) |
MEDTRONIC NAVIGATION, INC. (LOUISVILLE) |
826 coal creek circle |
|
louisville CO 80027 |
|
Manufacturer Contact |
peter
verhey
|
attn:product quality experienc |
826 coal creek circle |
louisville, CO 80027-9710
|
7208902515
|
|
MDR Report Key | 7084571 |
MDR Text Key | 93817695 |
Report Number | 1723170-2017-04960 |
Device Sequence Number | 1 |
Product Code |
HAW
|
UDI-Device Identifier | 00613994380005 |
UDI-Public | 00613994380005 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K001284 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
01/03/2018 |
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 |
Physician
|
Device Model Number | FUSION |
Device Catalogue Number | 9733560XOM |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/15/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/08/2017 |
Initial Date FDA Received | 12/05/2017 |
Supplement Dates Manufacturer Received | 12/06/2017
|
Supplement Dates FDA Received | 01/03/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/11/2009 |
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 |