BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, U1.6 SJ4 US

    MDR report key: 10254496 · Received July 9, 2020

    Report

    Report Number
    2017865-2020-08944
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 30, 2020
    Report Date
    August 26, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734504386
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SUBCUTANEOUS INFLAMMATION AND SWELLING OF THE IMPLANT POCKET OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DUE TO INFECTION. THE PHYSICIAN DID NOT ALLEGE THAT THE INFECTION WAS CAUSED OR CONTRIBUTED BY THE DEVICE. ON J(B)(6) 2020, THE PATIENT PRESENTED TO THE HOSPITAL AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS SUCCESSFULLY REMOVED. THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715119 FORTIFY DR, U1.6 SJ4 US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2231-40Q 3202265 05414734504386

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other| R