BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENSITE MULTI-ELECTRODE ARRAY CATHETER

    MDR report key: 1050215 · Received May 22, 2008

    Report

    Report Number
    2184149-2008-00006
    Event Type
    Death
    Date Received
    May 22, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ST. JUDE MEDICAL, ESI
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE SERIAL NUMBER IS THE ARRAY CATHETER AND ENSITE SYSTEM ARE UNK. THE MFR. REORDER AND LOT NUMBER OF THE ASSOCIATED ABLATION CATHETER ARE UNK. THE CAUSE FOR THE REPORTED STROKE AND SUBSEQUENT PT DEATH REMAIN UNK. THE FACILITY HAS NOT FILED A COMPLAINT ON THE PERFORMANCE OF THE ENSITE SYSTEM OR THE ARRAY CATHETER. THE PHYSICIAN DOES NOT ALLEGE THAT THE EVENT WAS CAUSED BY USE OF THE ENSITE SYSTEM OR THE ARRAY CATHETER. NO ADD'L INFO IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADD'L INFO REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED SVT ABLATION ENDED NORMALLY. HOWEVER, TWELVE HOURS POST PROCEDURE, THE PT EXPERIENCED A STROKE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSITE MULTI-ELECTRODE ARRAY CATHETER ARRAY CATHETER DRF ST. JUDE MEDICAL, ESI NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ANTICOAGULANTS - UNK