BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA CRT-D

    MDR report key: 3192375 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10954
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. CONCOMITANT PRODUCTS: 419688 IMPLANTABLE PACING LEAD IMPLANTED: 2010 (B)(6); 693565 IMPLANTABLE TACHY LEAD IMPLANTED: 2010 (B)(6); 507 6-45 IMPLANTABLE PACING LEAD IMPLANTED: 2007 (B)(6). (B)(4).

    Description of Event or Problem · 1

    A CALL WAS RECEIVED FROM THE CLINICIAN REQUESTING REVIEW OF A REMOTE MONITOR TRANSMISSION. THE TRANSMISSION OCCURRED DUE TO TRIGGERING OF A LEAD INTEGRITY ALERT (LIA). DURING THE CONVERSATION IT WAS REPORTED THAT THE PATIENT IS DECEASED. TECHNICAL SERVICE REVIEW OF THE TRANSMISSION WITH THE CLINICIAN NOTED THAT THE PATIENT HAD VENTRICULAR FIBRILLATION (VF) AND RECEIVED SIX SHOCKS WITHOUT SUCCESSFULLY TERMINATING THE RHYTHM. THE LIA IS NOTED TO BE DUE TO NONPHYSIOLOGIC SENSING AND ELEVATED SHORT INTERVAL COUNTS (SIC). ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH AND CIRCUMSTANCES OF DEATH HAVE BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294620 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 00061 YR Death