BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC CARELINK MONITOR

    MDR report key: 1843408 · Received September 24, 2010

    Report

    Report Number
    2183613-2010-00152
    Event Type
    Death
    Date Received
    September 24, 2010
    Date of Event
    August 25, 2010
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DXH
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD 3 VF (VENTRICULAR FIBRILLATION) EPISODES, BUT ONLY ONE "WAS ACTUALLY TRANSMITTED TO THE CARELINK WEBSITE." THE PATIENT WAS FOUND DEAD 2 DAYS LATER IN HIS BED. 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 MEDTRONIC CARELINK MONITOR PATIENT MONITORING INSTRUMENT DXH MEDTRONIC MILACA INC. MEDT/CLM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death D284TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB