BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA AV

    MDR report key: 23530448 · Received November 12, 2025

    Report

    Report Number
    9612164-2025-05572
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 30, 2025
    Report Date
    January 6, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00763000078669
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME [MICRA] PRODUCT ID [MC1AVR1-DELSYS] (SERIAL: (B)(6). 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.

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: A PARTIAL DELIVERY SYSTEM WAS RETURNED AND ANALYZED. THE LUMEN OF THE DELIVERY SYSTEM WAS TORN. THE ANALYST NOTED A PARTIAL DELIVERY SYSTEM WAS RETURNED WITHOUT THE DEVICE, TETHER, AND TETHER PIN. THE TETHER COULD NOT BE ANALYZED AS IT WAS NOT RETURNED. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED H6 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

    IT WAS REPORTED DURING IMPLANT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), AFTER THE PATIENT UNDERWENT TRICUSPID VALVE REPAIR, THE FIRST IMPLANTATION OF THE LEADLESS IPG SHOWED A GOOD THRESHOLD. SUBSEQUENT TESTING REVEALED AN INCREASED THRESHOLD, SO THE DEVICE WAS RETRIEVED AND REDEPLOYED. AFTER REDEPLOYMENT, THE THRESHOLD WAS HIGH, INDICATING LOSS OF CAPTURE. MULTIPLE ATTEMPTS WERE MADE TO REDEPLOY, BUT THE THRESHOLD REMAINED HIGH. AFTER REMOVING THE DELIVERY SYSTEM (DS), A SIGNIFICANT AMOUNT OF THROMBUS WAS FOUND. AFTER REMOVING THE THROMBUS, IMPLANTATION CONTINUED, AND THE PACING PARAMETERS DECREASED TO NORMAL RANGE. A TRACTION TEST SHOWED THAT THE TWO ANCHORING HOOKS WERE WELL-SECURED. THE SUTURE WAS THEN CUT TO PREPARE FOR REMOVAL OF THE DS TETHER. DURING THE REMOVAL PROCESS, THE SURGEON REPORTED THAT THE TETHER WAS TIGHT, BUT A HEARTBEAT WAS STILL FELT. AFTER REMOVING APPROXIMATELY FIFTY CENTIMETERS, FLUOROSCOPY REVEALED THAT THE LEADLESS IPG HAD DETACHED FROM ITS ORIGINAL ANCHORING POSITION, SO THE DEVICE WAS SUBSEQUENTLY REMOVED. MEDICATIONS AND TEMPORARY PACING WAS REQUIRED. THE LEADLESS IPG AND DS WAS ATTEMPTED/NOT USED. NO PATIENT COMPLICATIONS HA VE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645354 MICRA AV LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1AVR1 00763000078669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention