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

Model Number RFDEUK-10

Device Problem Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2022

Event Type  malfunction  

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 Description

Related manufacturer report numbers: 2184149-2022-00197, 2184149-2022-00198, 2184149-2022-00199.2184149-2022-00201, 2184149-2022-00202, 2184149-2022-00203.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
• Type of Device: 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: 15337325
• MDR Text Key: 305581115
• Report Number: 2184149-2022-00200
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 05415067028990
• UDI-Public: 05415067028990
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K011387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1