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

Model Number	RFG-4-120V
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a burn from the grounding pad site.
Additional Manufacturer Narrative
Analysis of the returned rfg-4-120v lot g4-1446 revealed that the available information in the complaint did not find or reveal any fault condition within the product.The product operates as intended with no issues.
Event or Problem Description
It was reported that a patient had a burn from the grounding pad site.

• 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): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13175655
• Report Number: 3006630150-2021-07478
• Device Sequence Number: 20047994
• Product Code: GXD
• UDI-Device Identifier: 08714729968313
• UDI-Public: 08714729968313
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: G4-1446
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2016
• 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