BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3872929 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11828
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    March 5, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350021 UNIFY ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention