BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 4843412 · Received June 15, 2015

    Report

    Report Number
    3010215456-2015-00481
    Event Type
    Injury
    Date Received
    June 15, 2015
    Report Date
    April 24, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AND THE SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388580 FORTIFY ASSURA DR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. (CRM-KISTA) CD2359-40C 4116312

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7001/65 S/N (B)(4)| 1688T/52 S/N (B)(4)