MAUDE Adverse Event Report: ST. JUDE MEDICAL (AFD-PLYMOUTH) DISPOSABLE GROUNDING PAD W/CABLE

Model Number	RF-DGP-S
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Contact Dermatitis (4546)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is estimated.
Event or Problem Description
It was reported that the patient had multiple yellow color like burns on their skin following an rfa procedure.The patient does not feel pain and any burning sensations.No further information is available at this time.
Additional Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Additional Manufacturer Narrative
Correction h6: coding corrected to 2017 - improper or incorrect procedure or method.

• Brand Name: DISPOSABLE GROUNDING PAD W/CABLE
• Common Device Name: GROUNDING PAD
• Manufacturer (Section D): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 20878855
• Report Number: 3005334138-2024-00525
• Device Sequence Number: 7804845
• Product Code: GEI
• UDI-Device Identifier: 05415067023629
• UDI-Public: 05415067023629
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/02/2025

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: 08/14/2025
• Device Model Number: RF-DGP-S
• Device Catalogue Number: RF-DGP-S
• Device Lot Number: 2023815
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 02/24/2025; 05/30/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 02/26/2025; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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