BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA CRT-D

    MDR report key: 1905437 · Received November 23, 2010

    Report

    Report Number
    2647346-2010-00742
    Event Type
    Death
    Date Received
    November 23, 2010
    Date of Event
    August 8, 2010
    Report Date
    September 19, 2019
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #002 SHOULD HAVE BEEN SEQUENCED #001, SO THIS REPORT IS BEING SUBMITTED AS A PLACEHOLDER WITH THE SEQUENCE #001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S SISTER THAT HE HAD BEEN FOUND DEAD IN HIS APARTMENT OVER THE WEEKEND AND QUESTIONED IF AN AUTOPSY SHOULD BE PERFORMED TO DETERMINE IF DEATH "MAY HAVE BEEN DUE TO THE DEVICE." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP REVEALED PATIENT HAD BEEN EVALUATED IN THE ER ON (B)(6) 2010 AND WAS FOUND TO HAVE HAD VENTRICULAR TACHYCARDIA THAT HAD BEEN ABORTED BY THE DEVICE. THE PATIENT REFUSED HOSPITAL ADMISSION AND WAS DISCHARGED "IN SATISFACTORY CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R| D LEAD/STJ IMPLANTABLE PACING LEAD