BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY PLUS DR RF

    MDR report key: 3920733 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14346
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 12, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS CONFIRMED THAT IT WAS DIFFICULT TO INSERT THE TEST LEAD INTO THE PULSE GENERATORS HEADER AND THE LEAD INSERTION FORCE USED TO INSERT THE LEAD WAS OUT OF SPECIFICATION FOR THE PRODUCT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, PULSE GENERATOR HEADER WOULD NOT ACCEPT THE LEAD. THE DEVICE WAS NOT IMPLANTED AND A NEW DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397000 ASSURITY PLUS DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1