BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTHEM RF

    MDR report key: 4121712 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07616
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 7, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREMATURE ELECTIVE REPLACEMENT INDICATOR WAS NOTED. IT WAS RESOLVED BY RESTORING THE FIRMWARE. THE PT WOULD BE FOLLOWED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32535 ANTHEM RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION PM3210

    Patients

    Seq Age Sex Outcome Treatment
    1