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	03/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference: 2184149-2019-00047.During a l4-s1 rhizotomy procedure, a patient burn occurred.During the procedure, the generator displayed an unknown error message that a grounding pad issue occurred.The pad was adjusted and the lesion was started again.Towards the end of the last lesion site, the patient experienced pain.It was discovered that the patient had a second degree burn at the grounding pad site on the left flank.The procedure was abandoned.The grounding pad did not overlap with any other patches.There were no wrinkles or edges that were lifted.The skin was not prepped and placed on top of clean dry skin.The burn was cleaned with aloe vesta skin cleanser and silvadene cream 1% was applied on a sterile pad and placed with medipore tape.The patient was stable.
Additional Manufacturer Narrative
One disposable grounding pad was returned for investigation.Four images were submitted to product performance engineering.One image appeared to show the grounding pad with a residue on the surface of the pad.Three images appeared to show a burn on the left flank of the patient.The results of the investigation concluded that the device functioned as intended during a simulated lesion test.No functional anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported patient burns remains unknown.According to the disposable grounding pad instructions for use ¿failure to achieve good skin contact by the entire surface of the grounding pad may result in significant electrosurgical burns at the pad location.Check the pad contact thoroughly before treatment.Do not reuse or relocate the grounding pad after initial contact.¿.

• 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: 8505852
• Report Number: 2182269-2019-00039
• Device Sequence Number: 1515713
• Product Code: GXD
• UDI-Device Identifier: 05415067028921
• UDI-Public: 05415067028921
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 05/23/2019

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: 10/23/2020
• Device Model Number: RF-DGP-S
• Device Lot Number: 20181024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 04/11/2019; 05/13/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 04/30/2019; 05/23/2019
• 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; 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR