BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURITY DR

    MDR report key: 3920751 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14337
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD INSERTION INTO THE PULSE GENERATOR HEADER WAS DIFFICULT. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396242 ENDURITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR