BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1694311 · Received May 19, 2010

    Report

    Report Number
    2017865-2010-02309
    Event Type
    Death
    Date Received
    May 19, 2010
    Date of Event
    October 29, 2009
    Report Date
    May 18, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, AND VOLUNTARY MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE ER COMPLAINING OF BEING SHOCKED AND SEVERE CHEST PAIN. IT WAS DETERMINED THAT THE LEAD HAD PERFORATED THE LEFT VENTRICLE. THE LEAD WAS REPOSITIONED. ON (B) (6) 2009, PATIENT WAS ADMITTED TO THE HOSPITAL AFTER DEVELOPING PNEUMONIA. LATER, PATIENT EXPIRES FROM CARDIAC ARREST SECONDARY TO PNEUMONIA AND ELECTROLYTE IMBALANCE. FAMILY BELIEVES THAT THE DELAY OF CARE CONTRIBUTED TO CONTRACTION OF PNEUMONIA AND SUBSEQUENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7121/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H| R