BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY PLUS DR RF

    MDR report key: 3920619 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14218
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN HAD DIFFICULTY CONNECTING THE PULSE GENERATOR TO THE LEAD. THE DEVICE WAS IMPLANTED AND THE PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396104 ASSURITY PLUS DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR