BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL PROBE COBRA

    MDR report key: 582140 · Received March 17, 2005

    Report

    Report Number
    2939222-2005-00008
    Event Type
    Death
    Date Received
    March 17, 2005
    Report Date
    March 17, 2005
    Manufacturer
    EP TECHNOLOGY - BSC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT PROCEDURE WAS A CARDIAC ABLATION, WHERE THE PT EXPIRED 6 DAYS POST OPERATIVE. SPOKE WITH RISK MANAGEMENT IN 2005, THEY WILL PULL THE PT FILE AND CONTACT REP WITH ADDITIONAL INFO. PRODUCT WAS DESTROYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL PROBE COBRA SURGICAL ABLATION PROBE LPB EP TECHNOLOGY - BSC M004 15927 0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Death