BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF ABLATION SYSTEM FOOT SWITCH

    MDR report key: 1232749 · Received November 14, 2008

    Report

    Report Number
    2953184-2008-00041
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    July 21, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC, EP TECHNOLOGIES
    Product Code
    LPB
    PMA / PMN Number
    P980003
    Removal / Correction Number
    PIR# 90461367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING FINAL INVESTIGATION RESULTS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETED. REMEDIAL ACTION HAS BEEN INITIATED, DUE TO THE PRELIMINARY INVESTIGATION INFO RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC IN 2008 THAT WHILE USING A FOOT SWITCH THE CUSTOMER EXPERIENCED THE FOLLOWING: 'WHEN PUSHING THE FOOTSWITCH CABLE CONNECTOR TO THE CONSOLE, SYSTEM STARTS TO ABLATE.' PRELIMINARY RESULTS FROM THE INVESTIGATION OF THIS DEVICE WAS RECEIVED ON OCTOBER 17, 2008. THE INFO INDICATES A MALFUNCTION OF THE FOOTSWITCH MAY CAUSE ACCIDENTAL ACTIVATION OF RF. DUE TO THE POTENTIAL RISK TO THE PT OR USER THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF ABLATION SYSTEM FOOT SWITCH FOOT SWITCH LPB BOSTON SCIENTIFIC, EP TECHNOLOGIES 21840 0634800361

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BLAZER| MAESTRO 3000 CONTROLLER