BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2160385 · Received July 13, 2011

    Report

    Report Number
    2649622-2011-10834
    Event Type
    Death
    Date Received
    July 13, 2011
    Date of Event
    June 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO A CARDIAC ARREST. THE EVENT WAS CAPTURED ON THE CARELINK MONITOR WHICH TRANSMITTED AN ALERT FOR "ALL THERAPIES EXHAUSTED" 3 HOURS AFTER THE EVENT DUE TO THE PHONE LINE BEING BUSY AT THE TIME THE EVENT OCCURRED. THE PATIENT RECIEVED 30 APPROPRIATE SHOCKS AND THE DEVICE FAILED TO SHOCK 14 TIMES BEFORE THE THERAPIES WERE EXHAUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death| L| O 2490C PATIENT MONITORING INSTRUMENT