BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 9742131 · Received February 21, 2020

    Report

    Report Number
    2182208-2020-00347
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    January 1, 2019
    Report Date
    February 21, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS. THE OVERALL BASELINE GENDER CHARACTERISTICS IS MALE; THE AGE OF THE PATIENTS WAS 69 YEARS OLD. 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: ¿SEPTAL IMPLANTATION OF THE MICRA TRANSCATHETER PACING SYSTEM GUIDED BY INTRAPROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAPHY.¿ KARDIOLOGIA POLSKA. 2019; 77(12):1190-1192.10.33963/KP.15043. 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 THIS MODEL OF TRANSCATHETER PACING SYSTEM (TPS). THE ARTICLE INDICATED THAT ONE PATIENT DEVELOPED ¿GRADUAL ELEVATION OF PACING THRESHOLD;¿ HOWEVER, THIS DID NOT REQUIRE ANY INTERVENTION. THE STATUS/LOCATION OF THE DEVICE IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203348 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC, INC. MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other