BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY PLUS DR RF

    MDR report key: 3920731 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14339
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 27, 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
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS CONFIRMED THAT IT WAS DIFFICULT TO INSERT THE TEST LEADS INTO THE ATRIAL AND VENTRICULAR CONNECTORS DUE TO A CONNECTOR DIAMETER ANOMALY.

    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 THE IMPLANT PROCEDURE, THE LEAD COULD NOT BE INSERTED INTO THE PULSE GENERATORS CONNECTOR HEADER. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396400 ASSURITY PLUS DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1