BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 9153162 · Received October 3, 2019

    Report

    Report Number
    9612164-2019-04222
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    August 1, 2018
    Report Date
    October 3, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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 WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: TROUBLESHOOTING IN PM LEADLESS: HOW TO MANAGE AN INDISSOLUBLE KNOT. JOURNAL OF ARRHYTHMIA. 2019. 35:676-678 DOI: 10.1002/JOA3.12211. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING A CASE STUDY INVOLVING MANAGEMENT OF AN INDISSOLUBLE KNOT IN A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DELIVERY SYSTEM. IT WAS REPORTED THAT DURING THE IMPLANT OF A LEADLESS IPG, THE APPROPRIATE POSITION HAD BEEN REACHED AND THE TUG TEST CONFIRMED SUCCESSFUL IMPLANTATION. HOWEVER, THE TETHER WAS PULLED BACK TO RELEASE THE IPG AND INCREASING RESISTANCE WAS MET. THE IPG WAS RECAPTURED INTO THE DELIVERY SYSTEM AND THE SYSTEM WAS REMOVED. THE DELIVERY SYSTEM WAS OBSERVED AND A KNOT WAS NOTED CLOSE TO THE DOCKING BUTTON WHICH BLOCKED THE RUNNING OF THE TETHER. A LONG CLOT WAS ALSO OBSERVED INSIDE THE DELIVERY SYSTEM. A NEW SYSTEM WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946325 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01-DELSYS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR