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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 Insufficient Heating (1287)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/30/2018
Type of Reportable Event Malfunction
Event or Problem Description
Device analysis was performed on the returned damaged electrode that was not heating.The complaint was confirmed.The shaft of the electrode was found to be completely separated from the hub.The probable cause is unintended use error caused or contributed to event.The separated shaft was likely due to unintended excessive external mechanical force.The shaft was not returned for analysis.The functional test could not be performed due to the separated shaft.
 
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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 Key7892118
Report Number3006630150-2018-60971
Device Sequence Number2366182
Product Code GXI
UDI-Device Identifier00813250010107
UDI-Public00813250010107
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/19/2018
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 NumberM241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2018
Initial Report FDA Received Date09/19/2018
Patient Sequence Number1
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