BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 10083252 · Received May 22, 2020

    Report

    Report Number
    2182208-2020-00935
    Event Type
    Injury
    Date Received
    May 22, 2020
    Date of Event
    August 1, 2009
    Report Date
    May 22, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/71 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 WAS MADE TO NO AVAIL. UPON RECEIPT OF NEW INFORMATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: A LOW CRITICAL EVENT RATE DESPITE A HIGH ABNORMAL EVENT RATE IN PATIENTS WITH CARDIAC IMPLANTABLE ELECTRIC DEVICES FOLLOWED UP BY REMOTE MONITORING. INTERNAL MEDICINE. 2019; 58(16):2333-2340. DOI: 10.2169/INTERNALMEDICINE.1905-18. 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 REMOTE MONITORING OF CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICES (CIEDS) INCLUDING IMPLANTABLE PULSE GENERATORS (IPGS), IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS). IT WAS REPORTED THAT OF ABOUT 16,560 TRANSMISSIONS FROM 1,849 PATIENTS OF VARIOUS MANUFACTURERS ANALYZED, ABNORMAL EVENTS INCLUDED: ATRIAL TACHYARRHYTHMIAS, VENTRICULAR TACHYARRHYTHMIAS, INAPPROPRIATE THERAPY, ABNORMAL BATTERY VOLTAGE, TRIGGERING ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY, AND ONE CASE OF UNEXPECTED BATTERY DEPLETION. LEAD IMPEDANCE ABNORMALITY, NON-PHYSIOLOGIC NOISE, SENSING AND PACING FAILURES, INCREASED ATRIAL AND VENTRICULAR PACING THRESHOLDS, DECREASED ATRIAL AND VENTRICULAR SENSING WERE ALSO OBSERVED. THE ARTICLE NOTED THAT FOR THE BASIS OF THIS STUDY, IN CLINIC INTERVENTION WAS NOT TRACKED, IT IS NOT KNOWN WHETHER INTERVENTION TOOK PLACE OR NOT. THE STATUS OF THE PRODUCTS ARE UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547278 MEDTRONIC PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening