BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 9072790 · Received September 16, 2019

    Report

    Report Number
    9612164-2019-03943
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Report Date
    September 25, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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: RETRIEVAL OF MEDTRONIC MICRA TRANSCATHETER PACING SYSTEM AFTER TETHER REMOVAL. EUROPACE. 2016. 18(8):1202. DOI: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE UNACCEPTABLE PARAMETERS COULD BE DESCRIBED AS HIGH THRESHOLDS.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THE RETRIEVAL OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) AFTER TETHER REMOVAL. IT WAS REPORTED THAT DURING THE IMPLANT, THE TETHER WAS CUT AND A SLIGHT RESISTANCE WAS NOTED WHEN THE TETHER WAS PULLED BACK. IT WAS THEN OBSERVED THAT THE PARAMETERS OF THE DEVICE WERE UNACCEPTABLE. THE DEVICE WAS SNARED AND RELEASED FROM THE MYOCARDIUM AND RETRIEVED BACK INTO THE INTRODUCER SHEATH. PERICARDIAL EFFUSION WAS RULED OUT VIA ECHOCARDIOGRAPHY AND A NEW LEADLESS IPG WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865824 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR