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

Model Number	RFG-4-120VH
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the electrode had a smell of smoke like perhaps something electrical is overheating inside the unit.
Event or Problem Description
It was reported that the electrode had a smell of smoke like perhaps something electrical is overheating inside the unit.
Additional Manufacturer Narrative
Rfg-4-120vh, sn: (b)(6).The returned generator was analyzed and visual inspection passed.No major damage or major scratches.Touch screen display is good.Connectors are good, footswitch connector is good.The field failure was not confirmed.

• Brand Name: NA
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• 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: 13558462
• Report Number: 3006630150-2022-00556
• Device Sequence Number: 3696246
• Product Code: GXD
• UDI-Device Identifier: 08714729968337
• UDI-Public: 08714729968337
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 04/01/2022

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: Health Professional
• Device Model Number: RFG-4-120VH
• Device Catalogue Number: RFG-4-120VH
• Device Lot Number: G4-1565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2016
• 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