BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 3071791 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06720
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    October 17, 2011
    Report Date
    February 18, 2013
    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 Location
    MO, 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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD - (B)(6) 2004. 5071 IMPLANTABLE PACING LEAD - (B)(6) 2004. (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 PRESENTED WITH SYMPTOMS OF HEART FAILURE, INCLUDING INCREASING EPISODES OF DYSPNEA, EDEMA, AND A LARGE LEFT EFFUSION. IT WAS NOTED VIA ELECTROCARDIOGRAM (ECG) THAT THE PATIENT WAS IN VENTRICULAR TACHYCARDIA (VT). IT WAS SUSPECTED THAT THE DEVICE ALGORITHM FAILED TO DETECT THE EPISODE OF VT, WHICH RESULTED IN A SUBSEQUENT FAILURE TO TREAT THE EPISODE. THE DEVICE REMAINS IN USE. THE PATIENT IS ENROLLED IN THE (B)(4) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172349 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Life Threatening 6947 IMPLANTABLE TACHY LEAD