BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY DR RF

    MDR report key: 3920626 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14229
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 23, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN HAD DIFFICULTY CONNECTING THE LEAD TO THE PULSE GENERATOR HEADER. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397141 ASSURITY DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PM2240, (B)(4)