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

Model Number	RFDE-SI
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results will be provided in the final report.Further information regarding the event were requested but not received.
Event or Problem Description
During a procedure, two of the three thermocouple modules on the simplicity probe were detached during the procedure.
Event or Problem Description
The procedure was completed with standard rf needles and both detached modules were accounted for outside of the patient.The patient was stable with no complications, however, is being followed at a clinic with persistent pain and is waiting an urgent mr.
Additional Manufacturer Narrative
One disposable simplicity electrode was received for investigation.The medial and proximal electrodes were detached exposing the conductor wires below.Abbott is performing further investigation.
Additional Manufacturer Narrative
One simplicity radiofrequency electrode was received for evaluation.The device was returned due to detached electrodes.The medial and proximal electrodes were detached exposing the conductor wires below.The probe was bent out of specification.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detached electrodes and bent probe is consistent with damage during use.

• Brand Name: DISPOSABLE SIMPLICITY ELECTRODE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9733334
• Report Number: 2182269-2020-00019
• Device Sequence Number: 13541897
• Product Code: GXI
• UDI-Device Identifier: 05415067028976
• UDI-Public: 05415067028976
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K011387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2020

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: 10/31/2021
• Device Model Number: RFDE-SI
• Device Catalogue Number: RFDE-SIRFDE-SI
• Device Lot Number: 6737143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/03/2020; 06/26/2020; 08/12/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 03/05/2020; 07/24/2020; 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1