BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 3881101 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02250
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 1, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    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 THERE WAS EVIDENCE OF T WAVE OVER SENSING ON A MERLIN TRANSMISSION. THE PATIENT DID NOT RECEIVE HV THERAPY. REPROGRAMMING WAS PLANNED FOR THE NEXT CHECK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30170 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK NIK ST. JUDE MEDICAL INC., CRMD CD3211-36

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR