BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2953509 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-02010
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MPRI
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 6947 IMPLANTABLE TACHY LEAD: (B)(6) 2010. 4194 IMPLANTABLE PACING LEAD: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THE PATIENT WAS IN A VENTRICULAR TACHYCARDIA AND WENT TO THE EMERGENCY DEPARTMENT. THE PATIENT'S VENTRICULAR RATE WAS BELOW THE DEFIBRILLATORS DETECT RATE RESULTING IN NO THERAPY. THE DETECTION RATE WAS CHANGED AND THE PATIENT WAS ABLE TO RECEIVE THERAPY ENDING THE TACHYCARDIA. IT WAS FURTHER NOTED THAT ATRIAL LEAD HAD UNDER SENSING THAT WAS UNRELATED TO WITHHOLDING THE THERAPY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56336 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MPRI D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Life Threatening| R 5076 IMPLANTABLE PACING LEAD