BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 21282855 · Received January 31, 2025

    Report

    Report Number
    9612164-2025-00543
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 1, 2024
    Report Date
    January 31, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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/68 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: LONG-TERM SAFETY AND EFFICACY OF INTRAOPERATIVE LEADLESS PACEMAKER IMPLANTATION DURING VALVE SURGERY. JACC CLINICAL ELECTROPHYSIOLOGY. 2024; 10:2224¿2233. DOI: 10.1016/J.JACEP.2024.06.018. 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 INTRAOPERATIVE IMPLANTATION OF LEADLESS IMPLANTABLE PULSE GENERATORS (IPGS) DURING VALVE SURGERY. THERE WAS ONE PATIENT WHO DEVELOPED COMPLETE HEART BLOCK AND VENTRICULAR PACING AT THE LOWER RATE OF 40 BEATS/MIN AND WAS REPROGRAMMED APPROXIMATELY THREE YEARS POST IMPLANT. BECAUSE OF SUBSEQUENT DETERIORATION IN LEFT VENTRICULAR EJECTION FRACTION, PACING-INDUCED CARDIOMYOPATHY WAS SUSPECTED, AND THE PATIENT UNDERWENT A REVISION TO REPLACE THE LEADLESS IPG. THERE WERE DEVICES WHICH EXHIBITED RISING AND ELEVATED PACING THRESHOLDS. 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
    2115754 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MDT-TPS-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male