BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURITY SR

    MDR report key: 3920608 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14201
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 28, 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
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP, THE PULSE GENERATOR EXHIBITED DEFAULT PROGRAMMING INSTEAD OF THE PARAMETERS THAT WERE SET DURING IMPLANT. THE DEVICE WAS REPROGRAMMED TO DESIRED PARAMETERS AND REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396343 ENDURITY SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM1160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1