BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3931638 · Received July 14, 2014

    Report

    Report Number
    2649622-2014-07643
    Event Type
    Death
    Date Received
    July 14, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCTS: PRODUCT ID: 5076-52, IMPLANTED: (B)(6) 2014; PRODUCT ID: UNK-COMP-LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY WITH CARDIAC ARREST AND PULSELESS ELECTRICAL ACTIVITY. IT WAS NOTED THAT AFTER THE ADMINISTRATION OF MEDICATION, CARDIOPULMONARY RESUSCITATION AND MECHANICAL VENTILATION THE PATIENT DIED. THE PATIENT WAS A PARTICIPANT OF THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411079 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Death DTBA2QQ ICD