Brand Name | STEALTHSTATION S7 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 |
sam
saleh
|
826 coal creek circle |
louisville, CO 80027
|
|
MDR Report Key | 6314387 |
MDR Text Key | 67114939 |
Report Number | 1723170-2017-00619 |
Device Sequence Number | 1 |
Product Code |
HAW
|
UDI-Device Identifier | 00613994450944 |
UDI-Public | 00613994450944 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K050438 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
02/09/2017 |
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 | S7 |
Device Catalogue Number | 9733856 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/07/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/17/2017 |
Initial Date FDA Received | 02/09/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |