BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT MRI DR

    MDR report key: 3920637 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14247
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 2, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE RETRACT THIS REPORT 2017865-2014-14247, THIS MEDICAL DEVICE SHOULD NOT HAVE BEEN REPORTED AS A MEDICAL DEVICE REPORT (MDR).

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INSTANCE OF NOISE HAD OCCURRED ON THE ATRIAL LEAD. THE NOISE COULD NOT BE REPRODUCED. THE PATIENT WOULD BE MONITORED.

    Description of Event or Problem · 1

    UPON REVIEW, THE PULSE GENERATOR SHOULD NOT HAVE BEEN SUBMITTED AS A MEDICAL DEVICE REPORT (MDR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398192 ACCENT MRI DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2224 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR