BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRONY K SR

    MDR report key: 3555650 · Received January 6, 2014

    Report

    Report Number
    2017865-2014-00593
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    October 17, 2013
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED A DIAGNOSTICS ANOMALY. AFTER CLEARING THE DIAGNOSTICS, NORMAL FUNCTION ENSUED. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6212 MICRONY K SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD 2535K NA

    Patients

    Seq Age Sex Outcome Treatment
    1