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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 TCN-10
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/07/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the electrode was broken at the hub.
 
Additional Manufacturer Narrative
Correction to initial mdr in blocks: e3 and h4.Analysis of the returned tcn-10 lot p273 revealed that the shaft of the electrode was found to be completely separated from the hub.The separated shaft was likely due to unintended excessive external mechanical force.
 
Event or Problem Description
It was reported that the electrode was broken at 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 Key11916863
Report Number3006630150-2021-02573
Device Sequence Number4199790
Product Code GXI
UDI-Device Identifier00813250013054
UDI-Public00813250013054
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K050084
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/24/2021
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 NumberTCN-10
Device Catalogue NumberTCN-10
Device Lot NumberP273
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2021
Initial Date Received by Manufacturer 05/07/2021
Supplement Date Received by Manufacturer06/09/2021
Initial Report FDA Received Date06/01/2021
Supplement Report FDA Received Date06/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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