BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA¿ VR2

    MDR report key: 22584898 · Received July 24, 2025

    Report

    Report Number
    9612164-2025-03599
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    May 21, 2025
    Report Date
    January 28, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00763000078683
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED: H10. 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: [MC2VR01-DELSYS], (SERIAL: [(B)(6)]. D9: NO, F1 USER FACILITY F2 UF/IMPORTER REPORT NUMBER: (B)(4), F3 USER FACILITY NAME/ADDRESS: (B)(6), F4 CONTACT PERSON: (B)(6), F5 PHONE NUMBER: (B)(6), F6 DATE USER FACILITY BECAME AWARE OF THE EVENT: UNKNOWN F7 TYPE OF REPORT: INITIAL F8 DATE OF THIS REPORT: JUN-2025 (DAY UNKNOWN) F9 APPROXIMATE AGE OF DEVICE: 6 MONTHS F10 EVENT PROBLEM CODES: PNJ F11 REPORT SENT TO FDA: UNKNOWN F12 LOCATION WHERE EVENT OCCURRED: USA F13 REPORT SENT TO MANUFACTURER: YES F14 MANUFACTURER NAME AND ADDRESS: MFR. NAME: MEDTRONIC ADDRESS: 8200 CORAL SEA STREET NE CITY: MOUNDS VIEW STATE: MN ZIP: 55112. 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. CONTINUATION OF D10: 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 [MC2VR01-DELSYS] (SERIAL: (B)(6). YES, RETURN DATE: 12 JAN 2026> FDR C07, C0706 FDC D15 FDM B01 PRODUCT EVENT SUMMARY OF DELIVERY SYSTEM: A PARTIAL DELIVERY SYSTEM WAS RETURNED AND ANALYZED. THE LUMEN OF THE DELIVERY SYSTEM WAS TORN. THE DELIVERY SYSTEM OUTER SHAFT WAS KINKED/BUCKLED. THE DELIVERY SYSTEM INNER SHAFT WAS MECHANICALLY KINKED/BENT. BLOOD WAS OBSERVED IN THE LUMEN OF THE DELIVERY SYSTEM. THE ANALYST NOTED A PARTIAL DELIVERY SYSTEM WAS RETURNED WITHOUT THE TETHER, AND TETHER PIN. AN ABBOTT SNARE SYSTEM WAS RETURNED SEPARATED FROM THE DELIVERY SYSTEM. THE OUTER SHAFT WAS KINK/BUCKLED AT 4.5 CM FROM THE DISTAL END OF THE DELIVERY SYSTEM. THE INNER SHAFT WAS KINKED AT 2 CM FROM THE DISTAL END OF THE RECAPTURE CONE. THE TETHER COULD NOT BE ANALYZED AS IT WAS NOT RETURNED WITH THE DELIVERY SYSTEM. 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 DURING IMPLANT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DEPLOYED EARLY AND DISLODGED. THE LEADLESS IPG WAS ATTEMPTED, NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717236 MICRA¿ VR2 LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC2VR01 00763000078683

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male