BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE QUADRA

    MDR report key: 3891178 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03573
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 3, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 THAT THE PATIENT CAME TO THE HOSPITAL AFTER AN ELECTRICAL STORM. THE CARDIOLOGIST TRIED TO INTERROGATE THE DEVICE WITHOUT SUCCESS. A MESSAGE APPEARED ON THE SCREEN THAT SAID CANNOT READ THE MEMORY CONTACT THE TECHNICAL SERVICES. TWO BUTTONS WERE ON THE SCREEN, ONE SAID PROGRAM, THE OTHER SAID SEND MESSAGE. THE CARDIOLOGIST DECIDED TO PUSH THE PROGRAM BUTTON AND THE DEVICE PROGRAMMED NO THERAPIES. AFTER THAT THE DEVICE WORKS WELL. HOWEVER, THE MEMORY OF THE DEVICE APPEARS TO BE DELETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28183 PROMOTE QUADRA IMPLANTABLE CARDIOVERTER DEFRIBILLATOR, NIK NIK ST. JUDE MEDICAL, INC., CRMD CD3239-40

    Patients

    Seq Age Sex Outcome Treatment
    1