BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3943935 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13390
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP, HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423688 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 7040/65,ABL14988,1788TC,BAM17590