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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION
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BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number CSK-TC10
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/04/2018
Type of Reportable Event Malfunction
Event or Problem Description
A report was received that the electrode was broken.The shaft broke off the hub.
 
Additional Manufacturer Narrative
A review of the manufacturing documentation for the product revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
 
Event or Problem Description
A report was received that the electrode was broken.The shaft broke off the hub.
 
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Brand Name
NA
Common Device Name
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key8026727
Report Number3006630150-2018-61607
Device Sequence Number16442761
Product Code GXI
UDI-Device Identifier00813250010107
UDI-Public00813250010107
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K050084
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/05/2018
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
Operator of Device Health Professional
Device Model NumberCSK-TC10
Device Catalogue NumberCSK-TC10
Device Lot NumberN634
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/04/2018
Supplement Date Received by Manufacturer11/14/2018
Initial Report FDA Received Date10/31/2018
Supplement Report FDA Received Date12/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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