BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1697516 · Received May 25, 2010

    Report

    Report Number
    6000144-2010-02042
    Event Type
    Death
    Date Received
    May 25, 2010
    Date of Event
    November 3, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 HER HUSBAND PASSED AWAY LAST NOVEMBER. "THE ICD DIDN'T GO OFF WHEN MY HUSBAND DIED AND I'M WONDERING IF IT WAS FAULTY. THE DEATH CERTIFICATE SAYS IT WAS A MASSIVE HEART ATTACK." FURTHER REPORTS THE PATIENT WAS HAVING ISSUES FOR A COUPLE WEEKS BEFORE HE DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE PATIENT'S DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S WIFE THAT HER HUSBAND PASSED AWAY LAST (B) (6). "THE ICD DIDN'T GO OFF WHEN MY HUSBAND DIED AND I'M WONDERING IF IT WAS FAULTY. THE DEATH CERTIFICATE SAYS IT WAS A MASSIVE HEART ATTACK." FURTHER REPORTS, THE PATIENT WAS HAVING ISSUES FOR A COUPLE WEEKS BEFORE HE DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE PATIENT'S DEATH WAS DEVICE RELATED. FOLLOW UP WITH THE CLINIC REVEALED THE PATIENT HAD LAST BEEN SEEN IN (B) (6) 2008 AND "HE MOVED WITHOUT NOTICE."

    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 55 YR Death