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

Model Number	RFG-4-120VH
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was burned from grounding pad.
Event or Problem Description
It was reported that patient was burned from grounding pad.Additional information was received that patients burn was not caused by generator, but it was ground pad caused the burn.The patient just happened to already have a service plan in place for their generator g4-912, so they wanted to get the generator checked out or calibrated as a precaution.
Event or Problem Description
It was reported that patient was burned from grounding pad.Additional information was received that patients burn was not caused by generator, but it was ground pad caused the burn.The patient just happened to already have a service plan in place for their generator g4-912, so they wanted to get the generator checked out or calibrated as a precaution.
Additional Manufacturer Narrative
Rfg-4-120vh sn: (b)(6).The returned generator was analyzed, passed all tests performed, and exhibited normal device characteristics.

• 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): 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: 16421802
• Report Number: 3006630150-2023-00766
• Device Sequence Number: 6433060
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2023

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-4-120VH
• Device Catalogue Number: RFG-4-120VH
• Device Lot Number: G4-912
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 03/15/2023; 05/11/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/06/2023; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2014
• 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