BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA DR CRT-D

    MDR report key: 3903727 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12799
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380457 QUADRA ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 1458Q,BPP032333,