BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II CRT-D

    MDR report key: 3922919 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12730
    Event Type
    Death
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DECEASED WITH AN UNKNOWN CAUSE OF DEATH. IT WAS NOTED ON A DEVICE TRANSMISSION THAT THE DEVICE DETECTED THE RHYTHM AND DELIVERED ANTI-TACHYCARDIA PACING THERAPY FOLLOWED BY A SHOCK THAT A RHYTHM THAT HAD ACCELERATED AFTER THE ANTI-TACHYCARDIA PACING. POST SHOCK THE VENTRICULAR TACHYCARDIA CONTINUED. THERE WAS QUESTION IF THE DEVICE DELIVERED ADDITIONAL THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400282 MAXIMO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D284TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death 6947, 4194 LEADS