BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLS II

    MDR report key: 2223114 · Received August 17, 2011

    Report

    Report Number
    2223114
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 17, 2011
    Manufacturer
    SPECTRONECTICS
    Product Code
    MFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A LEAD EXTRACTION PROCEDURE WAS BEING PERFORMED TO REMOVE TWO PACEMAKER LEADS IMPLANTED 11 YEARS AGO. THERE WAS ONE RIGHT ATRIAL AND ONE RIGHT VENTRICULAR LEAD. THE SPECTRONETICS MACHINE WAS TURNED ON AND CALIBRATED APPROPRIATELY. A 12 FRENCH SLS II LASER SHEATH WAS CONNECTED TO THE MACHINE AND THE CALIBRATION BUTTON WAS PUSHED WITH NO RESPONSE. IT WAS REPEATED MULTIPLE TIMES WITH NO CALIBRATION DONE EFFECTIVELY. THE SPECTRONETICS REP WAS CALLED AND INSTRUCTED US TO WIPE OFF THE SENSOR WITH ALCOHOL AND DRY. THIS WAS RE-ATTEMPTED WITH NO SUCCESS. THEY ASKED US TO CLEAR THE SENSOR ON THE LASER MACHINE AND USE THE CONTROL SHEATH WHICH CALIBRATED FINE. THE LASER SHEATH WOULD STILL NOT CALIBRATE. THE REP THEN INFORMED US TO USE ANOTHER 12 FR LASER SHEATH. WE INSTITUTED A NEW 12 FR LASER SHEATH THAT CALIBRATED FINE WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLS II SHEATH, REMOVAL, PACEMAKER ELECTRODE MFA SPECTRONECTICS 500-001 C11D21B

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR