BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR, DF-4 CONNECTOR

    MDR report key: 4133715 · Received October 1, 2014

    Report

    Report Number
    2938836-2014-16273
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 26, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 SYSTEM WAS EXPLANTED DUE TO INFECTION. PATIENT WAS TREATED WITH ANTIBIOTICS. PATIENTS CONDITION WAS SATISFACTORY FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610893 FORTIFY ASSURA DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 0293/304495