BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

    MDR report key: 3773354 · Received April 25, 2014

    Report

    Report Number
    2029046-2014-00125
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2013
    Report Date
    April 14, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P990025/S9
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. CONCOMITANT BWI PRODUCTS: PRODUCT: CARTO® 3 SYSTEM, US CATALOG # FG540000, SERIAL # UNKNOWN. PRODUCT: LASSO®, US CATALOG # UNKNOWN, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE BELOW EVENT REPORTED INVOLVED A BWI PRODUCT (NAVISTAR RMT) WAS DESCRIBED IN THE SCIENTIFIC LITERATURE JOURNAL: ARCHIVES OF CARDIOVASCULAR DISEASE (2014) 107, 88¿95, PUBLISHED ON FEBRUARY 18TH, 2014. ALL INFORMATION HAS BEEN RECEIVED BY BIOSENSE WEBSTER QUALITY DEPARTMENT ON (B)(4) 2014. "THE PATIENT UNDERWENT PULMONARY VEIN ISOLATION (PVI) PROCEDURE, USING MANUAL TRANSSEPTAL APPROACH. SUBSEQUENTLY, THE PATIENT DEVELOPED PERICARDIAL EFFUSION. THE PATIENT WAS HEMODYNAMICALLY STABLE. NO SURGICAL INTERVENTIONS WERE PERFORMED. THE PATIENT WAS TREATED MEDICALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251711 ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR RMT UNKNOWN_NAVISTAR RMT

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening