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	08/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received that an electrode became separated from the hub.
Additional Manufacturer Narrative
Device analysis indicated that the complaint of the electrode being completely out of the hub.Was confirmed.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
A report was received that an electrode became separated from the hub.

• 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: 8981178
• Report Number: 3006630150-2019-04935
• Device Sequence Number: 16976673
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1