BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRA¿ AV2

    MDR report key: 23776617 · Received December 11, 2025

    Report

    Report Number
    9612164-2025-06126
    Event Type
    Death
    Date Received
    December 11, 2025
    Date of Event
    November 21, 2025
    Report Date
    February 26, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00763000916428
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 [MC2AVR1-DELSYS] (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: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. 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: THE FULL DELIVERY SYSTEM WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE DELIVERY SYSTEM OUTER SHAFT WAS KINKED/BUCKLED. VISUAL ANALYSIS OF THE DELIVERY SYSTEM INDICATED DAMAGE DURING USE. THE ANALYST NOTED THE FULL DELIVERY SYSTEM WAS RETURNED WITH THE DEVICE INTACT IN THE DEVICE CUP. THE OUTER SHAFT WAS KINK/BUCKLED AT 5.5 CM FROM THE DISTAL END OF THE DELIVERY SYSTEM. THERE WERE NO ANOMALIES FOUND WITH THE DISTAL EDGE OF THE DEVICE CUP. 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

    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 [MC2AVR1-DELSYS] (SERIAL: (B)(6)). CORRECTED H6: FDC CODE FOR MC2AVR1-DELSYS. 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 THAT THE PATIENT DIED WITHIN ONE DAY POST IMPLANT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). DURING PLACEMENT OF THE DEVICE, NO SUITABLE LOCATION FOR ANCHORING COULD BE FOUND, AND THE DEVICE CONTINUED TO SLIDE DEEPER INTO THE HINGE AREA. AS A RESULT, DEFLECTION WAS APPLIED TO DIRECT THE DELIVERY SYSTEM (DS) DOWNWARD, AND AN ATTEMPT WAS MADE TO PLACE THE DEVICE IN THE SEPTUM NEAR THE APEX. THE DS WAS ADVANCED, AND IT WAS CONFIRMED THAT THE TIP WAS FACING POSTERIORLY AT THE APEX. CONTRAST IMAGING WAS PERFORMED AT THAT SITE. AT THAT TIME, ACCUMULATION OF CONTRAST AGENT OUTSIDE THE ENDOCARDIUM, APPEARING AS A THIN FILM, WAS OBSERVED. THE PROCEDURE WAS HALTED AT THAT POINT, AND ECHOCARDIOGRAPHY WAS PERFORMED, REVEALING PERICARDIAL EFFUSION NEAR THE APEX. CARDIAC TAMPONADE WAS DIAGNOSED. THE PATIENT BECAME HYPOTENSIVE. THE LEADLESS IPG WAS NOT DEPLOYED AND WAS WITHDRAWN. HOWEVER, SINCE THE PERICARDIAL EFFUSION WAS NOT SEEN TO INCREASE ON ECHOCARDIOGRAPHY AND BLOOD PRESSURE REMAINED STABLE DESPITE BEING LOW, NEITHER PERICARDIAL DRAINAGE NOR THORACOTOMY WAS PERFORMED AT THAT TIME, AND THE PATIENT WAS OBSERVED ON THE WARD. LATER ON, SURGICAL DRAINAGE WAS PERFORMED, BUT THE PATIENT ULTIMATELY DIED DUE TO COMPLETE ATRIOVENTRICULAR (AV) BLOCK. IT WAS THOUGHT THAT THE DS TIP PERFORATED W HEN ADVANCING THE CATHETER TO THE APEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2796348 MICRA¿ AV2 LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC2AVR1 00763000916428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death