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	Device Overstimulation of Tissue (1991)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that the patient was shocked during an rf ablation procedure.
Additional Manufacturer Narrative
Analysis revealed that the complaint was not confirmed.However g4-2215 failed stim test.All 4 channels are over their specified limit.This can cause a higher stimulation output to patient.The g4 unit failed functional test.
Event or Problem Description
A report was received that the patient was shocked during an rf ablation 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
• MDR Report Key: 8384242
• Report Number: 3006630150-2019-00881
• Device Sequence Number: 1795523
• Product Code: GXD
• UDI-Device Identifier: 08714729968313
• UDI-Public: 08714729968313
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: G4-2215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other