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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL DISPOSABLE SIMPLICITY ELECTRODE; PROBE, RADIOFREQUENCY LESION
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ST. JUDE MEDICAL DISPOSABLE SIMPLICITY ELECTRODE; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number RFDE-SI
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/22/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
One simplicity radiofrequency electrode was received for evaluation.The distal and proximal electrodes were fractured and detached therefore functional testing was not possible.Further investigation revealed a kink in the shaft of the electrode.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the kink in the shaft and fractured electrodes remains unknown.
 
Event or Problem Description
This report is to advise of an event observed during analysis confirming detached electrodes on the device.
 
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Brand Name
DISPOSABLE SIMPLICITY ELECTRODE
Common Device Name
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
ST. JUDE MEDICAL
14901 deveau place
minnetonka MN 55345
MDR Report Key11314615
Report Number2182269-2021-00011
Device Sequence Number3692368
Product Code GXI
UDI-Device Identifier05415067028976
UDI-Public05415067028976
Combination Product (Y/N)N
Initial Reporter CountryGM
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 Physician
Type of Report Initial
Report Date (Section B) 02/11/2021
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 Date08/31/2021
Device Model NumberRFDE-SI
Device Catalogue NumberRFDE-SIRFDE-SI
Device Lot Number6609138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/08/2021
Initial Report FDA Received Date02/11/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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