BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3840874 · Received May 30, 2014

    Report

    Report Number
    2182208-2014-01204
    Event Type
    Death
    Date Received
    May 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. 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 LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). CORRESPONDENCE WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AT THE TIME OF THIS REPORT. THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO INDICATION ANY SPECIFICS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: LEFT VENTRICULAR LEAD POSITION AND OUTCOMES IN THE RESYNCHRONIZATION-DEFIBRILLATION FOR AMBULATORY HEART FAILURE TRIAL (RAFT). CANADIAN JOURNAL OF CARDIOLOGY. 2014;30(4):413-419. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE/SERIAL NUMBERS. THE ARTICLE IS A "PROSPECTIVELY-DEFINED [LEFT VENTRICULAR (LV)] LEAD POSITION SUBSTUDY." THE ARTICLE DESCRIBES THE ASSOCIATION OF LEFT VENTRICULAR (LV) LEAD (NO MANUFACTURER IDENTIFIED) PLACEMENT AND THE AGREEMENT OF SUCH BETWEEN PHYSICIANS. THE ARTICLE ALSO REFERENCES HOSPITALIZATIONS AND DEATHS FROM CARDIOVASCULAR CAUSE. THE ARTICLE STATED ¿THERE WAS NO SIGNIFICANT ASSOCIATION BETWEEN ANY LV LEAD POSITION GROUP AND THE COMPOSITE END POINT OF APPROPRIATE ICD THERAPY OR SUDDEN CARDIAC DEATH." FURTHER FOLLOW UP DID NOT YET PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318531 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death| H| R