BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1724595 · Received June 16, 2010

    Report

    Report Number
    6000144-2010-03010
    Event Type
    Death
    Date Received
    June 16, 2010
    Date of Event
    December 9, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SON WAS TALKING TO PATIENT, PATIENT BECAME UNRESPONSIVE. SON NOTED PATIENT'S BODY JERK FROM SHOCK DELIVERED BY DEVICE, PATIENT RESPONDED AND SEEMED OKAY. LATER THAT SAME EVENING, PATIENT AGAIN BECAME UNRESPONSIVE WHILE TALKING TO SON, 2 SHOCKS WERE ADMINISTERED BY DEVICE, CALL PLACED TO 911, BUT PATIENT NEVER RECOVERED. SON REPORTED HCP FELT CAUSE OF DEATH WAS CHRONIC HEART FAILURE. DEATH CERTIFICATE STATES CAUSE OF DEATH WAS VENTRICULAR FIBRILLATION. PATIENT HAD PERSONAL MEDICAL HISTORY OF HEART AND KIDNEY FAILURE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SON WAS TALKING TO PATIENT, PATIENT BECAME UNRESPONSIVE. SON NOTED PATIENT'S BODY JERK FROM SHOCK DELIVERED BY DEVICE, PATIENT RESPONDED AND SEEMED OKAY. LATER THAT SAME EVENING, PATIENT AGAIN BECAME UNRESPONSIVE WHILE TALKING TO SON, 2 SHOCKS WERE ADMINISTERED BY DEVICE, CALL PLACED TO 911, BUT PATIENT NEVER RECOVERED. SON REPORTED HCP FELT CAUSE OF DEATH WAS CHRONIC HEART FAILURE. DEATH CERTIFICATE STATES CAUSE OF DEATH WAS VENTRICULAR FIBRILLATION. PATIENT HAD PERSONAL MEDICAL HISTORY OF END STAGE HEART AND KIDNEY FAILURE, "SO NO HEROIC EFFORTS WERE PURSUED BY THE PATIENT AND/OR FAMILY." THE PATIENT EXPIRED AT HOME AND WAS NOT BROUGHT TO THE HOSPITAL. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. ADDITIONAL INFORMATION RECEIVED REPORTED PATIENT WAS PACEMAKER DEPENDENT, THE LAST CLINIC VISIT HAD BEEN (B)(6) 2009, NO AUTOPSY WAS PERFORMED, AND NO DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death