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	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference number: 2184149-2019-00197.During a cervical spine ablation procedure a patient burn occurred.Prior to the procedure no skin preparation was performed and the grounding pad was placed on the left scapular region, which was hairy.After radiofrequency ablation had been delivered, a superficial burn with blistering was noted under the grounding pad.The pad was removed but no treatment was required.The grounding pad was replaced and the procedure was continued with no further issues.The patient was discharged home in stable condition.
Additional Manufacturer Narrative
One rf disposable grounding pad was received for evaluation.One image was submitted to product performance engineering.The image appears to show a patient burn.The results of the investigation concluded that the device functioned as intended during a simulated lesion test.The presence of a hair-like foreign material on the grounding pad, in addition to the event description, is consistent with placement of the grounding pad over hair.The rf disposable grounding pad instructions for use (ifu) warns ¿avoid placement over scars, bony prominences, prosthesis, hair, or ecg electrodes.Failure to achieve good skin contact by the entire surface of the grounding pad may result in significant electrosurgical burns at the pad location¿.A review of receiving inspection results for this lot number confirmed the product was manufactured according to specifications.

• 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: 9237952
• Report Number: 2182269-2019-00183
• Device Sequence Number: 1935543
• Product Code: GXD
• UDI-Device Identifier: 05415067028921
• UDI-Public: 05415067028921
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/13/2019

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: 06/19/2021
• Device Model Number: RF-DGP-S
• Device Lot Number: 20190620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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: NT2000¿ PAIN MANAGEMENT RF GENERATOR; NT2000¿ PAIN MANAGEMENT RF GENERATOR
• Outcome Attributed to Adverse Event: Other