BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 4771498 · Received May 8, 2015

    Report

    Report Number
    MW5042674
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 6, 2015
    Manufacturer
    ST. JUDE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS FOUND ON REMOTE CHECK TO HAVE ICD GEN MALFUNCTION WITH LOW IMPEDANCES, COMPLETE BATTERY DEPLETION AND NO HIGH ENERGY THERAPIES. HE HAS A HISTORY OF VT REQUIRING ICD THERAPY, VT ABLATION AND ANTIARRHYTHMIC DRUGS. HE WAS EMERGENTLY ADMITTED TO VBM FOR GENERATOR CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305457 FORTIFY ASSURA DR DEFIBRILLATOR LWS ST. JUDE CD2257-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R ATOVSTATIN 20MG PO QHS| SPIRONOLACTONE 25MG| MULTIVITAMIN 1 PO DAILY| TORSEMIDE 20MG PO BID| VITAMIN D3 PO DAILY| MAGNESIUM OXIDE 400MG PO BID| ENELAPRIL 5MG PO QHS| GLIMEPIRIDE 4MG PO BID| METFORMIN 1000MG PO BID| COREG 6.25MG PO BID| POTASSIUM CHLORIDE 40MEQ PO DAILY