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	Burn(s) (1757)
Date of Event	07/22/2019
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 number: 3002953813-2019-00051.During a bilateral lumbar radiofrequency ablation procedure, a patient burn occurred.The skin was prepped, and the grounding pad was placed on a non-hairy part of the posterior thigh.No alarms were noted throughout the procedure but upon removal of the grounding pad a second-degree burn was noted.The patient was started on antibiotics for treatment.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported patient burn could not be conclusively determined.

• 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: 8875880
• Report Number: 2182269-2019-00111
• Device Sequence Number: 2536698
• 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): 08/30/2019

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: 08/01/2020
• Device Model Number: RF-DGP-S
• Device Lot Number: 20180802
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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: Required Intervention
• Patient Weight: 83