BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTHEM RF

    MDR report key: 3920499 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14124
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z0430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REVIEWING OF THE STORED ELECTROCARDIOGRAMS, NOISE WAS NOTED ON THE VENTRICLE CHANNEL OF THE PULSE GENERATOR. THE NOISE COULD NOT BE REPRODUCED WITH ISOMETRICS. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395717 ANTHEM RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM3210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR (B)(4)