BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTHEM RF

    MDR report key: 4140499 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05820
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 14, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC WITH A PULSE GENERATOR THAT EXHIBITED LOW LEAD IMPEDANCE. OBTAINING A DEVICE IMAGE TO REVIEW THE INTEGRITY OF THE LEAD WAS SUGGESTED. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30172 ANTHEM RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI PM3210

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR