BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTHEM RF

    MDR report key: 4072320 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16302
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    July 1, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 PATIENT WAS NOT FEELING WELL AND WAS EXPERIENCING HEART PALPITATIONS. THE PULSE GENERATOR EXHIBITED LOSS OF ATRIAL CAPTURE AND INTERMITTENT ATRIAL SENSING. THE DEVICE WAS REPROGRAMMED AND REMAINED IMPLANTED. THE PATIENT HAD NO SUBSEQUENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555128 ANTHEM RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM3210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR