MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION

Model Number	TCN-15-3M
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received that an rf electrode became detached from the hub.The electrode will be sent back for analysis.
Additional Manufacturer Narrative
Record review revealed no additional information related to the complaint, therefore the probable cause selected is "no problem detected".
Event or Problem Description
A report was received that an rf electrode became detached from the hub.The electrode will be sent back for analysis.Additional information was received that the device was not returned for analysis.

• Brand Name: NA
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 9192863
• Report Number: 3006630150-2019-05763
• Device Sequence Number: 2549936
• Product Code: GXI
• UDI-Device Identifier: 00813250017519
• UDI-Public: 00813250017519
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K050084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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 Number: TCN-15-3M
• Device Catalogue Number: TCN-15-3M
• Device Lot Number: 23014524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1