MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. DISPOSABLE GROUNDING PAD W/CABLE

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	10/23/2019
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 third degree burn could not be conclusively determined.
Event or Problem Description
Following a left lumbar radiofrequency ablation procedure a third degree burn occurred at the grounding pad site.When the procedure was completed and the grounding pad was disconnected from the generator and removed, redness and blistering was observed at the right lower lumbar region where the grounding pad had been placed.The grounding pad had not overlapped any other pad, there were no wrinkles or lifted edges as well.The patient was noted to have dry skin.Tape and gauzed were applied to the burn and a triple antibiotic ointment was recommended.On (b)(6) 2019 the customer was informed the second degree burn had progressed into a third degree burn and burn ointment was prescribed for treatment.

• Brand Name: DISPOSABLE GROUNDING PAD W/CABLE
• Common Device Name: DISPOSABLE GROUNDING PAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9310179
• Report Number: 2182269-2019-00237
• Device Sequence Number: 10879586
• Product Code: GXD
• UDI-Device Identifier: 05415067028921
• UDI-Public: 05415067028921
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/24/2020
• Device Model Number: RF-DGP-S
• Device Lot Number: 20181225
• 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: 10/23/2019
• Initial Report FDA Received Date: 11/12/2019
• 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
• Patient Age: 24 YR
• Patient Weight: 93