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	Partial thickness (Second Degree) Burn (2694)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference: 2184149-2018-00207.During an ablation procedure, a patient burn occurred.The patient experienced a burning pain at the grounding pad location and the procedure was stopped.Blisters were noted around the perimeter of the grounding pad located on the lateral hip.There were four blisters with varying sizes.The pad was removed and a new grounding pad was placed on the opposite side of the body on the same area.The lesion was then able to be completed with no additional issues.The burn was treated with triple antibiotic ointment with padded tegaderm and the patient is being followed.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis; however, four images were submitted for evaluation.The images appear to show that the patient had several burns in multiple locations where the grounding pad had been placed.Visual inspection was based solely upon a review of the photographs received.The device was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the patient burn remains unknown.

• 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: 8170903
• Report Number: 2182269-2018-00144
• Device Sequence Number: 19197344
• Product Code: GXD
• UDI-Device Identifier: 05415067028921
• UDI-Public: 05415067028921
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,Followup
• Report Date (Section B): 01/22/2019

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: 07/01/2020
• Device Model Number: RF-DGP-S
• Device Lot Number: 20180702
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/22/2019
• 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: 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR
• Outcome Attributed to Adverse Event: Other