BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY DR RF

    MDR report key: 4072321 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16304
    Event Type
    Malfunction
    Date Received
    September 9, 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 Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR CONNECTOR WOULD NOT ACCEPT THE LEAD. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555743 ASSURITY DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR