MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-ST. PAUL) DISPOSABLE RADIOFREQUENCY ELECTRODE, 10CM; PROBE, RADIOFREQUENCY LESION

Model Number	RFDEUK-10
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Patient information cannot be provided due to personal data privacy legislation/policy.
Event or Problem Description
Related manufacturer report numbers: 2184149-2022-00197, 2184149-2022-00198, 2184149-2022-00199, 2184149-2022-00200, 2184149-2022-00201, 2184149-2022-00202.During the procedure, there was a missing impedance error message, and the generator stopped working after the sensory and motor testing.The procedure could not be completed.However after the procedure, during troubleshooting, the electrode was replaced and the generator was functioning properly.

• Brand Name: DISPOSABLE RADIOFREQUENCY ELECTRODE, 10CM
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15337392
• Report Number: 2184149-2022-00203
• Device Sequence Number: 6889773
• Product Code: GXI
• UDI-Device Identifier: 05415067028990
• UDI-Public: 05415067028990
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K011387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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: 12/31/2024
• Device Model Number: RFDEUK-10
• Device Catalogue Number: RFDEUK-10
• Device Lot Number: 8313476
• 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: 08/08/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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