BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, U1.6 SJ4 US

    MDR report key: 7381711 · Received March 29, 2018

    Report

    Report Number
    2017865-2018-04605
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    April 7, 2014
    Report Date
    March 29, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED (2938836-2014-130300). (B)(4). LITHIUM CLUSTERS WERE OBSERVED DURING THE ANALYSIS. NO ADDITIONAL ANALYSIS IS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE ERI. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223590 FORTIFY DR, U1.6 SJ4 US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2231-40Q 3169093

    Patients

    Seq Age Sex Outcome Treatment
    1