BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURITY DR

    MDR report key: 3920750 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14333
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 18, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION INCLUDED. FINAL ANALYSIS CONFIRMED THAT IT WAS DIFFICULT TO INSERT THE TEST LEAD INTO THE PULSE GENERATORS HEADER, AND THE INSERTION FORCE USED TO INSERT THE LEAD WAS OUT OF SPECIFICATION FOR THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-IMPLANT, THE PULSE GENERATOR EXHIBITED HIGH IMPEDANCE ON VENTRICULAR CHANNEL. AN X-RAY SHOWED THAT THE LEAD WAS NOT FULLY INSERTED IN THE HEADER AND THE POCKET WAS REOPENED. THE LEAD WAS DETACHED FROM THE DEVICE WITH SOME DIFFICULTY. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396065 ENDURITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention