BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO VARIABLE

    MDR report key: 2656568 · Received July 16, 2012

    Report

    Report Number
    2029046-2012-00104
    Event Type
    Injury
    Date Received
    July 16, 2012
    Date of Event
    June 25, 2012
    Report Date
    June 25, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K031161
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER REF # (B)(4) ARE RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, ERROR 8 APPEARED AND ALL BS ECG'S WERE LOST. AFTER REBOOTING THE PIU, THE LASSO CATHETER BEGAN RAPIDLY PACING THE LA ON ITS OWN, NO STIM ROUTING ON EITHER CARTO 3 OR BARD RECORDING SYSTEMS. THIS PACING PUT THE PATIENT INTO AFIB, WHICH QUICKLY RESOLVED ON ITS OWN. REPLACING THE LASSO CABLE AND THE LASSO CATHETER DID NOT RESOLVE THE ISSUE. THE CUSTOMER DISCONNECTED AND RECONNECTED THE LASSO CATHETER FROM PIU AND PACING RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO VARIABLE CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) LASSO VARIABLE UNKNOWN_LASSO VAR

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR