BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURITY DR

    MDR report key: 3920668 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14264
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 29, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: FINAL ANALYSIS CONFIRMED THAT IT WAS DIFFICULT TO INSERT THE TEST LEAD(S) 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 ONE DAY POST-IMPLANT, LOSS OF ATRIAL SENSING AND HIGH IMPEDANCE WERE NOTED. UPON FLUOROSCOPY THE LEAD WAS NOTED TO BE IN THE RIGHT LOCATION. THE PHYSICIAN DECIDED TO REVISE THE IMPLANT SITE AND FOUND THAT THE LEAD WAS NOT PROPERLY SECURED IN THE CONNECTOR AREA. IT WAS DIFFICULT TO INSERT THE LEAD INTO THE HEADER OF THE PULSE GENERATOR. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396884 ENDURITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention