Brand Name | STEALTHSTATION S8 PREMIUM 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
|
navigation customer quality |
826 coal creek circle |
louisville, CO 80027-9710
|
|
MDR Report Key | 7522600 |
MDR Text Key | 108622366 |
Report Number | 1723170-2018-02104 |
Device Sequence Number | 1 |
Product Code |
HAW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K162309 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
06/15/2018 |
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 Catalogue Number | 9735665 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/21/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/20/2018 |
Initial Date FDA Received | 05/17/2018 |
Supplement Dates Manufacturer Received | 05/22/2018
|
Supplement Dates FDA Received | 06/15/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |