BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTHEM RF

    MDR report key: 2014028 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01838
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    December 21, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4) COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, INTERROGATION OF THE PULSE GENERATOR REVEALED THAT THE ATRIAL CHANNEL WAS UNDERSENSING P-WAVES. FURTHER TESTING WAS PLANNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR