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

Model Number	CU-151020U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fistula (1862)
Date of Event	07/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the rf procedure, the area around the needle puncture site on the skin turned slightly pale, the patient then developed localized darkening of the skin, which later ulcerated.The patient was hospitalized, imaging was performed and confirmed that a fistula formed between the skin and the joint cavity of the procedure site.The patient was also prescribed antibiotics for ten days.

• Brand Name: ELECTRODEECHOCU
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 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: 22695573
• Report Number: 3006630150-2025-06109
• Device Sequence Number: 8250954
• Product Code: GXI
• UDI-Device Identifier: 00813250016291
• UDI-Public: (01)00813250016291(17)280411(10)33818138
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2025

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: CU-151020U
• Device Catalogue Number: CU-151020U
• Device Lot Number: 33818138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/02/2025
• Date Device Manufactured: 04/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 75 KG