BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 21422000 · Received February 20, 2025

    Report

    Report Number
    9612164-2025-00931
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    December 1, 2024
    Report Date
    February 20, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. 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/79 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. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: IMPACT OF BODY MASS INDEX ON IN-HOSPITAL OUTCOMES IN PATIENTS RECEIVING LEADLESS PACEMAKERS: A FIVE-CATEGORY ANALYSIS. HEART RHYTHM O2. 2024; 5:883¿889. DOI: 10.1016/J.HROO.2024.09.017 THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: BRAND NAME: MICRA PRODUCT ID: MDT-TPS-DELSYS, D9: NO 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 IMPACT OF BODY MASS INDEX ON IN-HOSPITAL OUTCOMES IN PATIENTS RECEIVING LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE SPECIFIC CAUSES OF DEATH WERE UNKNOWN AND DESCRIBED AS IN-HOSPITAL MORTALITY. THERE WERE PATIENTS WHO EXPERIENCED VENOUS THROMBOEMBOLISMS, CARDIOGENIC SHOCK, BLEEDING COMPLICATIONS WHICH REQUIRED BLOOD TRANSFUSIONS, PERICARDIAL COMPLICATIONS, RENAL COMPLICATIONS, AND DEVICES WHICH REQUIRED REMOVALS OR REVISIONS FOR UNKNOWN REASONS. PERICARDIAL COMPLICATIONS INCLUDED NONINFECTIVE ACUTE PERICARDITIS, NONINFLAMMATORY PERICARDIAL EFFUSION, NONTRAUMATIC HEMOPERICARDIUM, CARDIAC TAMPONADE, AND UNSPECIFIED PERICARDIAL COMPLICATIONS. RENAL COMPLICATIONS INCLUDED ACUTE KIDNEY INJURY. BLEEDING COMPLICATIONS COVERED PERIPROCEDURAL BLEEDING, POSTPROCEDURAL ANEMIA, AND HEMOPERITONEUM/RETROPERITONEAL BLEEDING. THE STATUS OF THE LEADLESS IPGS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383923 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MDT-TPS-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization| L| R