BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 8604606 · Received May 13, 2019

    Report

    Report Number
    2182208-2019-00878
    Event Type
    Death
    Date Received
    May 13, 2019
    Date of Event
    April 8, 2018
    Report Date
    May 13, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH MODEL/ SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/(B)(6) YEARS OLD. 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: T WAVE POSITIVITY IN LEAD AVR IS ASSOCIATED WITH MORTALITY IN PATIENTS WITH CARDIAC RESYNCHRONIZATION THERAPY JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2018; 53(1):41-46. 10.1007/S10840-018-0364-9. 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 LEFT VENTRICULAR, RIGHT VENTRICULAR AND RIGHT ATRIAL LEADS. THE AUTHORS DISCUSSED THE RELATIONSHIP BETWEEN POSITIVE T WAVE POLARITY AND MORTALITY. THE POSITIVE T WAVE POLARITY CHANGES DEVELOPED IMMEDIATELY AFTER IMPLANTATION. ADDITIONALLY, THE ARTICLE SHOWED THE ELECTRICAL IMPULSES TO THE RIGHT ATRIUM AND RIGHT VENTRICLE MAY INCREASE ELECTRICAL INSTABILITY AND MAY BE THE REASON FOR POSITIVE T WAVE POLARITY AND RE-POLARIZATION OF LEFT VENTRICULAR PACING. THE RE-POLARIZATION MAY BE ARRHYTHMOGENIC WHICH COULD BE THE REASON FOR INCREASED CHANCES OF DEATH. THE DECEASED PATIENTS WERE FOUND DEAD IN THEIR BEDS OR DIED IN THE HOSPITAL DUE TO WORSENING HEART FAILURE AND THE AUTHORS STATED THAT ARRHYTHMIAS COULD BE THE REASON FOR THE DEATHS. THE STATUS/DISPOSITION OF THE LEADS IS NOT KNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398568 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death