BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1810601 · Received August 23, 2010

    Report

    Report Number
    2647346-2010-00491
    Event Type
    Death
    Date Received
    August 23, 2010
    Date of Event
    September 24, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    Z-0126-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 BY THE PATIENT'S WIFE THAT "HE (PATIENT) SUPPOSEDLY RECEIVED 7 SHOCKS WHILE IN THE HOSPITAL. SOMEONE CAME TO CHECK THE DEVICE AND MADE SOME CHANGES. WHEN THEY WHEELED HIM IN FOR SURGERY HE DIED." DEVICE INTERROGATION LATER REVEALED NO OVERT LOSS OF INTEGRITY, ALL IMPEDANCES WITHIN EXPECTATIONS, ALL DELIVERED ENERGY LEVELS WITHIN EXPECTATIONS, SIC (SHORT INTERVAL COUNTER) EVENTS ARE ASSOCIATED WITH NORMAL VF (VENTRICULAR FIBRILLATION) SENSING AND DETECTION. 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.

    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 31 YR Death 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD