BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURITY DR

    MDR report key: 4231218 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18042
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 1, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS CONFIRMED THAT IT WAS DIFFICULT TO INSERT THE TEST LEADS 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 DURING IMPLANT OF THE PULSE GENERATOR, THE PHYSICIAN WAS UNABLE TO FULLY INSERT A LEAD INTO THE ATRIAL HEADER PORT. THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714744 ENDURITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR (B)(4)