BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3822493 · Received May 21, 2014

    Report

    Report Number
    2182208-2014-01193
    Event Type
    Death
    Date Received
    May 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. 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: PULMONARY FLUID OVERLOAD MONITORING IN HEART FAILURE PATIENTS WITH SINGLE AND DUAL CHAMBER DEFIBRILLATORS. J. CARDIOVASC. MED. 2014;15(4):307-314. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. FAILURE MODES WERE REFERENCED IN THE ARTICLE, WITH NO SPECIFIC ICD MODEL FAILURE INDICATIONS. THE FAILURE MODES WERE NOTED AS: ¿FALSE POSITIVE HEART FAILURE EPISODES,¿ URGENT HEART TRANSPLANTATION, AND DEATHS. IT WAS ALSO NOTED THAT THE ALERTS WERE TURNED OFF FOR SOME PATIENTS. SOME PATIENTS REACTED TO THE ALERTS BY ¿SELF-ADJUSTING¿ THEIR MEDICATIONS, AND SOME PATIENTS DID NOT HEAR THE ALERTS. THE DEATHS WERE NOTED TO BE FROM CARDIOVASCULAR CAUSES; HOWEVER, WITH NO DIRECT ICD-DEATH RELATEDNESS INDICATED. FURTHER FOLLOW UP DID NOT YET PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303760 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death| R