BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 17246013 · Received July 3, 2023

    Report

    Report Number
    9612164-2023-02949
    Event Type
    Injury
    Date Received
    July 3, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 3, 2023
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: D1: MICRA D4:MODEL#: MC1VR01-DELSYS / EXPIRATION DATE:16 JUNE 2024 / SERIAL#: (B)(6) / UDI #: (B)(4) / D9: NO Y DEV RTN TO MFR? NO / H4: MFG DATE: 20 DEC 2022 / H5: YES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), WHEN THE LEADLESS IPG WAS PLACED IN THE SEPTUM, THE DEVICE DISLODGED DURING FIXATION CHECK. THE LEADLESS IPG WAS RETRIEVED AND SECOND DEPLOYMENT WAS CARRIED OUT. IT WAS NOTED THAT THE DEPLOYMENT BUTTON ON THE DS SLID TO THE END, HOWEVER THE DEVICE ONLY HALF DEPLOYED. THE DEVICE AND DS WAS REMOVED FROM THE PATIENT AND ON INSPECTION THE DS APPEARED KINKED. ON FLUOROSCOPY CONTRAST LEAKAGE WAS NOTED IN THE EPICARDIUM. ECHOCARDIOGRAM CONFIRMED PERICARDIAL EFFUSION DUE TO PERFORATION. THE PHYSICIAN COMMENTED THAT THE DURING DEVICE PLACEMENT ISSUES MAY HAVE CAUSED THE PERFORATION. THE PROCEDURE WAS ABANDONED AND TRANSVENOUS PACEMAKER IS PLANNED. HOSPITALISATION WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20725 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 104 YR Female Required Intervention| H| L