BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3953185 · Received July 23, 2014

    Report

    Report Number
    2938836-2014-13601
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF FAR P WAVE OVERSENSING AND INAPPROPRIATE THERAPY WERE NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE REPORTED ANOMALIES COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ATP THERAPY DUE TO FAR P-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE. THERE WERE NO NEGATIVE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431603 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention