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

Model Number	RFG-4-120V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a burn on patients skin.The blister was noticed after the grounding pad was removed.It was reported that the application site was not clean and the grounding pad was applied posterior to the right thigh.The patient was provided silvadene ointment and the patients blister was healing appropriately.
Event or Problem Description
It was reported that the patient had a burn on patients skin.The blister was noticed after the grounding pad was removed.It was reported that the application site was not clean and the grounding pad was applied posterior to the right thigh.The patient was provided silvadene ointment and the patients blister was healing appropriately.
Additional Manufacturer Narrative
Rfg-4-120v (sn (b)(6)).The returned rf generator was analyzed, passed all tests performed, and exhibited normal device characteristics.With all the available information, boston scientific concludes that the grounding pads were at fault for the burn (mfr.Report no.3006630150-2022-05905) and not the generator.The unit passed all visual and functional tests despite the overlap in the recommended calibration date for preventive maintenance.

• 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15734221
• Report Number: 3006630150-2022-05939
• Device Sequence Number: 2868826
• Product Code: GXD
• UDI-Device Identifier: 08714729968313
• UDI-Public: 08714729968313
• Combination Product (Y/N): N
• 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): 01/30/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RFG-4-120V
• Device Catalogue Number: RFG-4-120V
• Device Lot Number: G4101331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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