BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 4760308 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04687
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    December 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO INFECTION. PATIENT DOING VERY WELL POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302641 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3357-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention