BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE QUADRA

    MDR report key: 3891179 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03572
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    May 4, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY THE MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE INTERROGATING THE DEVICE A MESSAGE CALL TECHNICAL SUPPORT OR BACK TO NOMINAL VALUES APPEARED. WHEN THE CLINICIAN WENT BACK TO NOMINAL VALUES, HE HAD GOT THE OUT OF BOX SETTINGS. AFTER REPROGRAMMING AND SENDING PATIENT TO HOME, HE SAW THE PATIENT NEXT DAY AND PARAMETERS WERE FINE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31119 PROMOTE QUADRA IMPLANTABLE CARDIOVERTER DEFRIBILLATOR, NIK NIK ST. JUDE MEDICAL, INC., CRMD CD3239-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1