MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. DISPOSABLE GROUNDING PAD W/OUT CABLE; PROBE, RADIOFREQUENCY LESION

Model Number	RF-DGP-L
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results will be provided in a subsequent submission. .
Event or Problem Description
Following a 4-level unilateral lumbar ablation procedure, a burn was noted after removing the grounding pad.The grounding pad had left a clear film on the patient following removal and a blister was noted on the skin under the left flank.The patients skin was not prepped before placing the grounding pad.The patient is in stable condition.
Additional Manufacturer Narrative
One image was submitted to product performance engineering.The image appears to show a clear film was noted on the surface of the grounding pad.Further investigation revealed the grounding pad was assembled with the clear film on the inside layer of the blue liner.

• Brand Name: DISPOSABLE GROUNDING PAD W/OUT CABLE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8730589
• Report Number: 2182269-2019-00084
• Device Sequence Number: 19450878
• Product Code: GXD
• UDI-Device Identifier: 05415067028914
• UDI-Public: 05415067028914
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2019

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: Health Professional
• Device Expiration Date: 03/11/2021
• Device Model Number: RF-DGP-L
• Device Lot Number: 810319005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 08/01/2019; 10/14/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/30/2019; 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q419-NM_EP-1
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other