BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 4153552 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16311
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING AN ALERT FOR OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE. THE POCKET WAS OPENED AND THE LEADS WERE REINSERTED AND THE SETSCREW TIGHTENED. AFTER THE POCKET WAS CLOSED ALL MEASUREMENTS WERE NORMAL. THE NEXT DAY, THE PATIENT RETURNED WITH THE SAME OUT OF RANGE HIGH VOLTAGE IMPEDANCE ALERT. THE ALERT WAS CLEARED. THE PATIENT CONDITION WAS NORMAL. THERE HAVE BEEN NO FURTHER ISSUES REPORTED AND THE PATIENT HAS NOT YET RETURNED TO THE CLINIC FOR FURTHER DEVICE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631840 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2357-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention MEDT 6947, TDG106289V