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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSMAN MEDICAL CSK-TC ELECTRODE; ELECTRODES
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COSMAN MEDICAL CSK-TC ELECTRODE; ELECTRODES Back to Search Results
Model Number CSK-TC10-3M
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2018
Event Type  malfunction  
Manufacturer Narrative
Expiration date: na.
 
Event Description
The device analysis on the returned electrode revealed that the electrode shaft was broken right at the hub.The functional test could not be performed due to the broken hub.
 
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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 Key7555526
MDR Text Key109622942
Report Number3006630150-2018-01939
Device Sequence Number1
Product Code GXI
UDI-Device Identifier00813250011524
UDI-Public00813250011524
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050084
Number of Events Reported1
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 NumberCSK-TC10-3M
Device Lot Number042915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/14/2018
Initial Date FDA Received05/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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