BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATLAS II PLUS DR

    MDR report key: 2231699 · Received September 1, 2011

    Report

    Report Number
    2017865-2011-05351
    Event Type
    Death
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH AND OUR AUTOMATED TESTING EQUIPMENT. NO ANOMALY FOUND. THE DEVICE MET ALL SPECIFICATIONS AND WAS FOUND TO BE NORMAL.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE PATIENT FELL OFF A BOAT INTO A LAKE AND SANK QUICKLY. POST EXAM SHOWED NO WATER IN LUNGS AND A MULTIPLE DRUG TOXICITY. PATHOLOGIST SUSPECTED DRUG OVERDOSE; HOWEVER, DEVICE FUNCTION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death (B)(4)