MAUDE Adverse Event Report: ST. JUDE MEDICAL (AFD-PLYMOUTH) DISPOSABLE SIMPLICITY ELECTRODE; RFDE-SI PROBE

Model Number	RFDE-SI
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a radiofrequency ablation procedure on (b)(6) 2024, the probe was overheating and patient experienced pain local.As a result, the procedure was aborted.
Additional Manufacturer Narrative
It was reported to abbott during a radio frequency surgery there was a problem with high temperature, not allowing the procedure to be completed.A simplicity ii ionic generator had been used.The surgery was cancelled.The probe was discarded.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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: DISPOSABLE SIMPLICITY ELECTRODE
• Common Device Name: RFDE-SI PROBE
• Manufacturer (Section D): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19506659
• Report Number: 3005334138-2024-00228
• Device Sequence Number: 11651285
• Product Code: GXI
• UDI-Device Identifier: 05415067028976
• UDI-Public: (01)05415067028976(10)10015540(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K011387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: RFDE-SI
• Device Catalogue Number: RFDE-SI
• Device Lot Number: 10015540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown