BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 8515892 · Received April 15, 2019

    Report

    Report Number
    2182208-2019-00716
    Event Type
    Death
    Date Received
    April 15, 2019
    Date of Event
    May 24, 2018
    Report Date
    April 15, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US AND ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/65 YEARS OLD. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: "ICD LEAD TYPE AND RV LEAD POSITION IN CRT-D RECIPIENTS." CLINICAL RESEARCH IN CARDIOLOGY (2018) 107:1122¿1130, HTTPS://DOI.ORG/10.1007/S00392-018-1286-3. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATION DEVICES AND RIGHT VENTRICULAR LEADS. THE AUTHORS STUDIED RV APICAL VERSUS NON-APICAL LEAD POSITIONS AND DETERMINED THERE WAS NO ASSOCIATION RELATIVE TO OUTCOME. ALL CAUSE MORTALITY AND CARDIOVASCULAR DEATH WAS ASSESSED. THE CAUSE OF DEATH FOR SOME PATIENTS WAS CARDIOVASCULAR IN NATURE AND FOR OTHERS IT WAS OF NON-VASCULAR ORIGIN. THERE WERE CASES OF PATIENT DEATH WHERE THE PRECISE CAUSE COULD NOT BE DETERMINED. THE STATUS/DISPOSITION OF THE PRODUCTS IS NOT KNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308346 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death