BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II DR

    MDR report key: 3943879 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13412
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    May 30, 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
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP, FAR-FIELD R-WAVE OVERSENSING ON THE ATRIAL CHANNEL WAS OBSERVED. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE MADE. PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421821 ATLAS II DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-265 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR