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

Model Number	TCN-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a burn line at the right hip where the electrode was set.This was confirmed a user error by the physician.Based on the investigation, the physician was using 5 needles using the 4 electrodes.The physician placed the electrode onto the side of the patient in which normally is not what the physician does.The physician used the 5th needle on the wrong electrode inside the patient.The electrode that was on the side of the patient should have been the one used for the 5th needle.This is what caused the patient injury burn.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: rfa-rf generator, upn: m365sc2218700, model: rfg-4-120v, serial: (b)(6), batch: (b)(6).
Event or Problem Description
It was reported that the patient had a burn line at the right hip where the electrode was set.This was confirmed a user error by the physician.Based on the investigation, the physician was using 5 needles using the 4 electrodes.The physician placed the electrode onto the side of the patient in which normally is not what the physician does.The physician used the 5th needle on the wrong electrode inside the patient.The electrode that was on the side of the patient should have been the one used for the 5th needle.This is what caused the patient injury burn.
Additional Manufacturer Narrative
Correction to the initial mdr in block h11.Rf generator should have not been added as additional suspect device.

• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17892497
• Report Number: 3006630150-2023-06109
• Device Sequence Number: 17989263
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TCN-10
• Device Catalogue Number: TCN-10
• Device Lot Number: 27250951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown