BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 3920890 · Received July 8, 2014

    Report

    Report Number
    2938836-2014-13322
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 21, 2006
    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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED ONE INAPPROPRIATE SHOCK FOR SINUS TACHYCARDIA. NO FURTHER ISSUES WERE SEEN AND DEVICE FUNCTION WAS NORMAL AT SUBSEQUENT FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398459 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR