BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 19332692 · Received May 16, 2024

    Report

    Report Number
    9612164-2024-02359
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    June 5, 2023
    Report Date
    May 16, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. 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/74 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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: IMPLANTATION OF THE MICRA SEAMLESS PACEMAKER (LP) ¿ ONE CENTER EXPERIENCE. VASA. 2023; 65:447¿453. DOI: 10.33678/COR.2022.104 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN. THERE IS NO ALLEGATION OF DEVICE-DEATH RELATEDNESS INDICATED IN THE ARTICLE AND THE AUTHORS COULD NOT FIND A CAUSAL RELATIONSHIP BETWEEN THE IMPLANT AND THE DEATHS. ONE PATIENT DEVELOPED A CARDIAC TAMPONADE WITH THE NEED FOR PERICARDIOCENTESIS, ONE PATIENT EXPERIENCED TRANSIENT ASYSTOLE DURING IMPLANTATION, AND ANOTHER PATIENT HAD SEVERE BLEEDING FROM THE PUNCTURE SITE WHICH CAUSED THE IMPLANT TO BE ABORTED. THE NEXT DAY, THE IMPLANT WAS PERFORMED ON THE OTHER SIDE. THERE WAS ONE LEADLESS IPG WHICH DISLODGED AFTER THE PROCEDURE, AND IT WAS EXTRACTED, AND A NEW DEVICE WAS IMPLANTED. THERE WERE LEADLESS IPG'S WHICH EXHIBITED SLIGHT DECREASES IN IMPEDANCE. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633822 MICRA INTRODUCER, CATHETER DYB MEDTRONIC IRELAND MI2355A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other