BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 19358750 · Received May 21, 2024

    Report

    Report Number
    9612164-2024-02428
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    January 1, 2023
    Report Date
    May 21, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    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. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS 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/73 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. REFERENCED ARTICLE: A COMPARATIVE STUDY OF THE TWO LEADLESS PACEMAKERS IN CLINICAL PRACTICE. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2023; 34:1896¿1903. DOI: 10.1111/JCE.16019 . 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 THIS LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE AUTHORS DESCRIBED ONE PATIENT WHO EXPERIENCED A GROIN HEMATOMA DURING THE IMPLANT WHICH RESOLVED WITH CONSERVATIVE TREATMENT. THERE WAS ONE LEADLESS IPG WHICH EXHIBITED A SIGNIFICANT INCREASE IN THRESHOLD ONE DAY POST IMPLANT. THE DEVICE WAS RETRIEVED AND REPLACED. 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
    1156270 MICRA INTRODUCER, CATHETER DYB MEDTRONIC IRELAND MI2355A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention