BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 9712056 · Received February 14, 2020

    Report

    Report Number
    2182208-2020-00299
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    January 1, 2019
    Report Date
    March 18, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE OVERALL BASELINE GENDER CHARACTERISTICS IS MALE; THE AGE OF THE PATIENTS WAS 78 YEARS OLD. 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: ¿MANAGEMENT OF ANTICOAGULATION IN PATIENTS UNDERGOING LEADLESS PACEMAKER IMPLANTATION.¿ HEART RHYTHM. 2019; 16(12):1849-1854. DOI: 10.1016/J.HRTHM.2019.05.016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION/ADDITIONAL INFORMATION: THIS NEW INFORMATION IS BASED ON THE SUBSEQUENT FOLLOW UP INFORMATION OBTAINED FROM THE AUTHOR. UPON INVESTIGATION, IT WAS DISCOVERED THAT THE INFORMATION IN THIS ARTICLE FOR PATIENT #2 (SYMPTOMATIC THROMBOSIS OF THE IPSILATERAL SAPHENOUS VEIN) WAS PREVIOUSLY REPORTED IN A TIMELY MANNER ON 2016-10-06, AND IS REPRESENTED IN THE REGULATORY REPORT NUMBER 9612164-2016-01054. THEREFORE, THIS IS A DUPLICATE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING A LEADLESS CARDIAC PACEMAKER (LCP) DEVICE. THE AUTHOR INDICATED THAT THERE WERE TWO PATIENTS WHO EXPERIENCED COMPLICATIONS. ONE PATIENT PRESENTED WITH A HEMORRHAGIC PERICARDIAL EFFUSION WITHOUT TAMPONADE; WHICH DID NOT REQUIRE DRAINAGE. ANOTHER PATIENT PRESENTED WITH ¿SYMPTOMATIC THROMBOSIS OF THE IPSILATERAL SAPHENOUS VEIN.¿ THIS PATIENT WAS GIVEN ADDITIONAL ANTICOAGULANT MEDICATION AND REQUIRED THREE ADDITIONAL DAYS OF HOSPITALIZATION. THE LOCATION OF THE DEVICE IS UNKNOWN; BUT APPEARS TO BE STILL IN USE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173800 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC, INC. MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R