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

Model Number	RFDE-SI
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure, the probe would not heat to temperature and there was a clinically significant delay in the procedure.Cables and settings were changed with no resolution.A second probe was used and the procedure was completed with no patient consequences.
Additional Manufacturer Narrative
One disposable simplicity electrode was returned for investigation.The reported temperature issue could not be confirmed.The device met specifications for temperature response and no short circuits were detected.No visual or functional anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported temperature issue and subsequent procedure delay remains unknown.

• 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: 8422693
• Report Number: 2182269-2019-00030
• Device Sequence Number: 2051131
• Product Code: GXD
• UDI-Device Identifier: 05415067028976
• UDI-Public: 05415067028976
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: RFDE-SI
• Device Lot Number: 6457249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other