BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURITY DR

    MDR report key: 3920641 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14253
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 16, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE REQUIRED LEAD INSERTION FORCE EXCEEDED SPECIFICATIONS IN THE ATRIAL AND RIGHT VENTRICULAR HEADER PORTS. HEADER PORT DIMENSIONS WERE ALL WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PULSE GENERATOR WOULD NOT ACCEPT A LEAD INTO THE RIGHT VENTRICULAR HEADER PORT. THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397158 ENDURITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR