MAUDE Adverse Event Report: ST. JUDE MEDICAL DISPOSABLE SIMPLICITY ELECTRODE; PROBE, RADIOFREQUENCY LESION

Model Number RFDE-SI

Device Problems High impedance (1291); Communication or Transmission Problem (2896)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

One simplicity radiofrequency electrode was received for evaluation.Investigation revealed the electrode shaft was bent out of specification, consistent with the reported issue and the open circuit.Electrode 2 and electrode 3 are detached revealing the conductor wires.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detached electrode and subsequent open circuit is consistent with damage during use.

Event Description

This report is to advise of an event observed during analysis confirming detached electrodes.

• Brand Name: DISPOSABLE SIMPLICITY ELECTRODE
• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12149297
• MDR Text Key: 260962548
• Report Number: 2182269-2021-00060
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 05415067028976
• UDI-Public: 05415067028976
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K011387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: RFDE-SI
• Device Catalogue Number: RFDE-SIRFDE-SI
• Device Lot Number: 7361177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2020
• 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