BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3584201 · Received January 21, 2014

    Report

    Report Number
    2938836-2014-04522
    Event Type
    Other
    Date Received
    January 21, 2014
    Date of Event
    November 17, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY THE MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASYMPTOMATIC PATIENT WAS PRESENTED TO EMERGENCY ROOM AFTER PATIENT NOTIFIER WAS TRIGGERED DUE TO POST PACED T WAVE OVERSENSING WITHOUT THERAPY. IT WAS RECOMMENDED TO REPROGRAM THE DEVICE FOR VENTRICULAR POST PACED THRESHOLD AND VENTRICULAR POST PACED DELAY. IT WAS ALSO RECOMMENDED TO DO AN INDUCTION TEST WITH NEW SETTINGS. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49177 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD CD2257-40

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male