MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COSMAN RFG-4; AMPLIFIER, PHYSIOLOGICAL SIGNAL

Model Number	RFG-4-120V
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient exhibited a burn near the needle site during the procedure.It was noted that the radiofrequency generator started smoking.
Additional Manufacturer Narrative
The returned rf-generator was analyzed, passed all tests performed, and exhibited normal device characteristics.
Event or Problem Description
It was reported that the patient exhibited a burn near the needle site during the procedure.It was noted that the radiofrequency generator started smoking.

• Brand Name: COSMAN RFG-4
• Common Device Name: AMPLIFIER, PHYSIOLOGICAL SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16441965
• Report Number: 3006630150-2023-00861
• Device Sequence Number: 20294727
• Product Code: GXD
• UDI-Device Identifier: 08714729968313
• UDI-Public: 08714729968313
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082051
• 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): 05/23/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RFG-4-120V
• Device Catalogue Number: RFG-4-120V
• Device Lot Number: G4200054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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 Age: 64 YR
• Patient Sex: Female