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	Bacterial Infection (1735)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed a mild bacterial infection.The patient was admitted to the hospital.No further details have been reported.
Event or Problem Description
It was reported that the patient developed a mild bacterial infection.The patient was admitted to the hospital.No further details have been reported.Additional information was received that this event was not related to the device and procedure.

• 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: 13664844
• Report Number: 3006630150-2022-00819
• Device Sequence Number: 20202356
• Product Code: GXD
• UDI-Device Identifier: 08714729968313
• UDI-Public: 08714729968313
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: Health Professional
• Device Model Number: RFG-4-120V
• Device Catalogue Number: RFG-4-120V
• Device Lot Number: G4-1386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• 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: Hospitalization
• Patient Sex: Female