BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURITY DR

    MDR report key: 3851792 · Received June 5, 2014

    Report

    Report Number
    2017865-2014-13811
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    May 3, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086/S230
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL AND EXTENSIVE TESTING FOUND NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO HOURS AFTER THE SYSTEM WAS IMPLANTED, THE PATIENT EXPERIENCED SHORTNESS OF BREATH. A CHEST X-RAY REVEALED PULMONARY EDEMA, THE PATIENT THEN COLLAPSED IN THE BED AND WAS UNRESPONSIVE WITH A SLOW HEART RATE. AN ECG REVEALED LOSS OF VENTRICULAR OUTPUT. THE PATIENT WENT INTO CARDIOPULMONARY ARREST AND CPR WAS PERFORMED. THE PATIENT RECOVERED CONSCIOUSNESS WITH SELF VENTILATION AND SPOKE, THEN EXPERIENCED CARDIAC ARREST AGAIN AND CPR WAS PERFORMED AGAIN. THE PULSE GENERATOR EXHIBITED INTERMITTENT LOSS OF VENTRICULAR AND ATRIAL OUTPUT AND THE POCKET WAS RE-OPENED. THE CONNECTION BETWEEN THE HEADERS AND LEADS WERE CHECKED TO BE SECURED AND THE LEADS WERE TESTED WITH A PSA AND REVEALED NORMAL VALUES. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE ICU BUT DECEASED ON (B)(6) 2014. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329162 ENDURITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death