MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) DISPOSABLE GROUNDING PAD W/CABLE; RFA GROUNDING PAD

Model Number	RF-DGP-S
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Contact Dermatitis (4546)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a radiofrequency lesioning procedure patient experienced burning sensation at grounding pad site.In turn, the procedure was stopped and grounding pad was removed.Red irritation/abrasion at site of grounding pad was noted.
Additional Manufacturer Narrative
It was reported that the product was used during radiofrequency lesioning procedure.Product was placed on patient's left lower side back.Once rfl machine was started, patient started to complain of burning sensation at grounding pad site.Procedure was stopped and grounding pad removed.Patient did have red irritation/abrasion at site of grounding pad.Pad discarded and supply chain notified.All lot numbers were pulled from production.Upon inspection - pad did have two small indents in the pad.Efforts to obtain additional event details have been unsuccessful.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: DISPOSABLE GROUNDING PAD W/CABLE
• Common Device Name: RFA GROUNDING PAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 20883829
• Report Number: 2182269-2024-00043
• Device Sequence Number: 21093209
• Product Code: GEI
• UDI-Device Identifier: 05415067023629
• UDI-Public: 05415067023629
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K111576
• 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): 06/10/2025

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 Expiration Date: 12/01/2025
• Device Model Number: RF-DGP-S
• Device Catalogue Number: RF-DGP-S
• Device Lot Number: 20231202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown