BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA CRT-D

    MDR report key: 6201679 · Received December 22, 2016

    Report

    Report Number
    3004209178-2016-27134
    Event Type
    Death
    Date Received
    December 22, 2016
    Date of Event
    December 24, 2013
    Report Date
    December 8, 2016
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. UF/IMPORTER REPORT NUMBER: MW5066261. (B)(6). DATE OF THIS REPORT: 2016-11-21. APPROXIMATE AGE OF DEVICE: 3 YEARS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A WITNESSED COLLAPSE, POSSIBLY AFTER USING AN ILLICIT SUBSTANCE. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS VENTRICULAR FIBRILLATION (VF) UNDERSENSING RESULTING IN FAILURE TO RESCUE. SIX EPISODES OF VF REQUIRING EXTERNAL DEFIBRILLATION WERE NOTED DURING EMERGENCY MEDICAL SERVICES RESCUE AND DOCUMENTED ON PARAMEDIC RUNS SHEET. HOWEVER, THE DEVICE ONLY RECORDED ONE EPISODE OF VF WHICH WAS TREATED BY THE DEVICE ADMINISTERED INTERNAL DEFIBRILLATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851514 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 65 YR Death 419588 LEAD, 694765 LEAD, 5076-52 LEAD