BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 5720905 · Received June 13, 2016

    Report

    Report Number
    2938836-2016-04927
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 25, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) # : P910023.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ATRIAL UNDERSENSING WAS OBSERVED IN ATRIAL CHANNEL. REVIEW OF SESSION RECORDS SHOWED THAT PATIENT WENT INTO CHRONIC AF AND P-WAVES WERE DECREASED IN AMPLITUDE DRAMATICALLY LEADING TO CONSISTENT ATRIAL UNDERSENSING. PROGRAMMING CHANGES WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375361 FORTIFY ASSURA DR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2359-40QC 4756580

    Patients

    Seq Age Sex Outcome Treatment
    1