BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURITY DR

    MDR report key: 3923114 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14449
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, INSERTION OF THE ATRIAL LEAD INTO THE PULSE GENERATOR CONNECTOR WAS DIFFICULT. AFTER THE POCKET WAS CLOSED, LOSS OF ATRIAL CAPTURE AND HIGH LEAD IMPEDANCE WERE OBSERVED. THE POCKET WAS REOPENED AND IT WAS NOTED THAT THE ATRIAL LEAD WAS NOT FULLY INSERTED INTO THE DEVICE CONNECTOR. AFTER RE-CONNECTING THE LEAD, NORMAL ELECTRICAL VALUES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401273 ENDURITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention