BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2021141 · Received March 16, 2011

    Report

    Report Number
    2647346-2011-00297
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    August 30, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE LEAD MODEL 6949 IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST IMPLANT OF THE RIGHT VENTRICULAR LEAD. FURTHER REVIEW REVEALED PATIENT DIED TWO MONTHS AFTER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR CAN AND RIGHT ATRIAL LEAD AS WELL. IT WAS ALSO NOTED THE PATIENT "EXPERIENCED SEVERE AND FREQUENT ELECTRIC SHOCKS," SUFFERED MENTAL ANGUISH AND EXTREME PHYSICAL INJURY.

    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 75 YR Death