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

Model Number RFDE-SI

Device Problem Impedance Problem (2950)

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

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

One simplicity radiofrequency electrode was received for evaluation.The device met specifications for temperature response and no short circuits were detected.No functional anomalies were noted; however the tubing was bent and electrode 3 was fractured but still attached.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported fracture remains unknown.

Event Description

This report is to advise of an event noted during analysis which revealed a fractured electrode.

• Brand Name: DISPOSABLE SIMPLICITY ELECTRODE
• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12007653
• MDR Text Key: 256458166
• Report Number: 2182269-2021-00055
• 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: Other
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• 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