BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 3801282 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10968
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    June 2, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SVT WITH RAPID VENTRICULAR RESPONSE. IT WAS SUSPECTED THAT MITRAL REGURGITATION WITH ENLARGED LEFT ATRIUM CONTRIBUTED TO THE ATRIAL ARRHYTHMIA. THE PATIENTS MEDICATIONS WERE ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278691 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention