BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 20452001 · Received October 15, 2024

    Report

    Report Number
    9612164-2024-04713
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 1, 2024
    Report Date
    October 15, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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/77 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. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ASSOCIATION OF CHRONIC KIDNEY DISEASE AND END-STAGE RENAL DISEASE WITH PROCEDURAL COMPLICATIONS AND INPATIENT OUTCOMES OF LEADLESS PACEMAKER IMPLANTATIONS ACROSS THE UNITED STATES. HEART RHYTHM. 2024; 21:1695¿1702. DOI: 10.1016/J.HRTHM.2024.03.1816. 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 ASSOCIATION OF CHRONIC KIDNEY DISEASE (CKD) AND END-STAGE RENAL DISEASE (ESRD) WITH OUTCOMES IN PATIENTS WITH LEADLESS IMPLANTABLE PULSE GENERATORS (IPGS). PATIENTS WERE STUDIED AND SPLIT INTO GROUPS OF NO CKD, CKD, AND ESRD. THE AUTHORS DESCRIBED PATIENT DEATHS EITHER INPATIENT PRIOR TO DISCHARGE OR AFTER DISCHARGE; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN. INPATIENT MORTALITY WAS MORE PREVALENT IN ESRD AND CKD PATIENTS UNDERGOING LEADLESS PACEMAKER IMPLANTATIONS COMPARED WITH NO-CKD PATIENTS. THERE WERE PATIENTS WHO EXPERIENCED PROCEDURE-RELATED COMPLICATIONS SUCH AS PERICARDIAL EFFUSION OF ANY BECAUSE WHICH REQUIRED INTERVENTION OR PERICARDIOCENTESIS, ACUTE KIDNEY INJURY, AND VASCULAR COMPLICATIONS WHICH INCLUDED PSEUDOANEURYSM, ARTERIOVENOUS FISTULA, ACCESS SITE HEMATOMA, RETROPERITONEAL BLEEDING, AND VENOUS THROMBOEMBOLISM. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295107 MICRA INTRODUCER, CATHETER DYB MEDTRONIC IRELAND MI2355A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other