BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITY DR

    MDR report key: 4083732 · Received January 10, 2014

    Report

    Report Number
    2017865-2014-01518
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    July 8, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED ELECTIVELY DUE TO APPROACHING ERI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18177 AFFINITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC. CRMD 5330L

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention