Brand Name | CSK-TC ELECTRODE |
Type of Device | ELECTRODES |
Manufacturer (Section D) |
COSMAN MEDICAL |
22 terry ave |
burlington MA 01803 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC NEUROMODULATION |
25155 rye canyon loop |
|
valencia CA 91355 |
|
Manufacturer Contact |
talar
tahmasian
|
25155 rye canyon loop |
valencia, CA 91355
|
6619494863
|
|
MDR Report Key | 7555526 |
MDR Text Key | 109622942 |
Report Number | 3006630150-2018-01939 |
Device Sequence Number | 1 |
Product Code |
GXI
|
UDI-Device Identifier | 00813250011524 |
UDI-Public | 00813250011524 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K050084 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
05/30/2018 |
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 | CSK-TC10-3M |
Device Lot Number | 042915 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/26/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/14/2018 |
Initial Date FDA Received | 05/30/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/29/2015 |
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 |