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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	10/17/2019
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: 2184149-2019-00198, 2182269-2019-00184, 2182269-2019-00186.During a cervical spine ablation procedure, the grounding pad was placed on the patient's right flank.While ablation was being performed the patient complained of a burning sensation from the grounding pad.The pad was removed but no burn or inflammation was noted.The grounding pad was replaced with the same lot number and placed on the patient's left side.The same issue occurred with the patient having a burning sensation.The grounding pad was replaced again with the same lot number, and the issue recurred.The procedure ended up being cancelled.There were no adverse consequences to the patient.
Event or Problem Description
Additional related manufacturer reference number: 2182269-2019-00241.
Additional Manufacturer Narrative
One rf disposable grounding pad was received for evaluation.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: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9237990
• Report Number: 2182269-2019-00185
• Device Sequence Number: 11315125
• Product Code: GEI
• 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): 11/22/2019

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: 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: 10/18/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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: DISPOSABLE GROUNDING PAD X2; NT2000¿ PAIN MANAGEMENT RF GENERATOR; DISPOSABLE GROUNDING PAD X2; NT2000¿ PAIN MANAGEMENT RF GENERATOR
• Outcome Attributed to Adverse Event: Other