BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2953682 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-02022
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 PRODUCTS: 4076, IMPLANTABLE PACING LEAD, - (B)(6) 2011; 4194, IMPLANTABLE PACING LEAD, - (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FAST VENTRICULAR TACHYCARDIA (VT), AND THE DEVICE SUCCESSFULLY DELIVERED ANTI-TACHY PACING (ATP) IN ORDER TO RESOLVE THE VT. HOWEVER, THE DEVICE SUBSEQUENTLY DELIVERED AN UNNECESSARY SHOCK, PLACING THE PATIENT INTO ANOTHER VT EVENT. THE DEVICE WILL BE REPROGRAMMED, AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55728 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6947 IMPLANTABLE TACHY LEAD