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

Model Number	TCN-10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Device analysis performed on the returned electrode revealed that the hub had a chipped piece of epoxy.

• 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: 8588591
• Report Number: 3006630150-2019-02124
• Device Sequence Number: 2191664
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 05/07/2019

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-10
• Device Catalogue Number: TCN-10
• Device Lot Number: 123115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1