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

Model Number	RFG-4-120VH
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Inappropriate Device Stimulation of Tissue (4928)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction

• Brand Name: NA
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel ; EI
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50151615
• Report Number: 3006630150-2026-05621
• Device Sequence Number: 9296742
• Product Code: GXD
• UDI-Device Identifier: 08714729968337
• UDI-Public: (01)08714729968337(11)211118(10)G4200254
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: Lay User/Patient
• Device Model Number: RFG-4-120VH
• Device Catalogue Number: RFG-4-120VH
• Device Lot Number: G4200254
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 11/18/2021
• 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: Other
• Patient Sex: Unknown