BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS DR

    MDR report key: 3892660 · Received June 24, 2014

    Report

    Report Number
    2938836-2014-12285
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    April 28, 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
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VIA MERLIN.NET TRANSMISSION, AN ALERT FOR PREMATURE ERI WAS RECEIVED. PATIENT IS HOSPITALIZED FOR A RESPIRATORY ISSUE AND DEVICE REVISION IS UNCERTAIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368993 CURRENT PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR