BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURITY DR

    MDR report key: 3920657 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14267
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 29, 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
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED AN ERROR. AFTER REBOOTING THE PROGRAMMER, THE DEVICE WAS INTERROGATED AND THE MESSAGE COULD NOT BE REPLICATED. THE PATIENT WOULD CONTINUE TO BE MONITORED WITH NORMAL FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397383 ENDURITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR