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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. DISPOSABLE SIMPLICITY ELECTRODE; PROBE, RADIOFREQUENCY LESION
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ST. JUDE MEDICAL, INC. DISPOSABLE SIMPLICITY ELECTRODE; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number RFDE-SI
Medical Device Problem Code Impedance Problem (2950)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/23/2020
Type of Reportable Event Malfunction
Additional 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 or Problem Description
This report is to advise of an event noted during analysis which revealed a fractured electrode.
 
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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 Key12007653
Report Number2182269-2021-00055
Device Sequence Number3304089
Product Code GXI
UDI-Device Identifier05415067028976
UDI-Public05415067028976
Combination Product (Y/N)N
Initial Reporter CountryMY
PMA/510(K) Number
K011387
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/16/2021
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 Date01/31/2023
Device Model NumberRFDE-SI
Device Catalogue NumberRFDE-SIRFDE-SI
Device Lot Number7361177
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/10/2021
Initial Report FDA Received Date06/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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