BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPLORER 360

    MDR report key: 2217454 · Received August 8, 2011

    Report

    Report Number
    2134070-2011-00010
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 8, 2011
    Manufacturer
    STERILMED, INC.
    Product Code
    NLH
    PMA / PMN Number
    K012523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS AN EP TECHNOLOGIES CATHETER. DURING USE, THE STAFF NOTICED NOISE AND WAS UNABLE TO PACE ELECTRICALLY. IT WAS CONFIRMED WITH (B)(4) AT THE FACILITY (B)(4), 2011 VIA A TELEPHONE CONVERSATION, THE PT EXPERIENCED NO INJURY AND THE CASE WAS COMPLETED WITH A NEW CATHETER. THE DEVICE IS SOUGHT FOR RETURN FROM THE USER FACILITY. IF AND WHEN THE DEVICE IS RETURNED FOR INVESTIGATION, MORE INFO WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESC: AFTER PLACING THE CATHETER IN THE RIGHT ATRIUM, NOTICED NOISE AND UNABLE OT PACE ELECTRICALLY. THE DEVICE IS A REPROCESSED PRODUCT BY STERILMED INC AND MFG BY EP TECHNOLOGIES. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? EP TESTING WITH INDUCTION OF ARRYTHMIA DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPLORER 360 CATHETER, RECORDING, ELECTRODE, REPROCES NLH STERILMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other