MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. DISPOSABLE GROUNDING PAD W/CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	RF-DGP-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Related manufacturer reference number: 2184149-2020-00126.During an l2-l5 ablation procedure the patient sustained third degree burns.The grounding pad had been placed on the posterior right thigh, on hairy skin that had not been prepared.During the procedure no alarms were experienced, and the procedure was completed with no performance issues.Upon removal of the grounding pad the patient was noted to have a third degree burn that was treated with silvadene.The patient has remained in stable condition.

• Brand Name: DISPOSABLE GROUNDING PAD W/CABLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 10458949
• Report Number: 2182269-2020-00078
• Device Sequence Number: 16859407
• Product Code: GEI
• UDI-Device Identifier: 05415067028921
• UDI-Public: 05415067028921
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K111576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 12/19/2021
• Device Model Number: RF-DGP-S
• Device Catalogue Number: RF-DGP-S
• Device Lot Number: 20191220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NT2000 PAIN MANAGEMENT RF GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention