BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 10014822 · Received April 30, 2020

    Report

    Report Number
    2182208-2020-00845
    Event Type
    Injury
    Date Received
    April 30, 2020
    Date of Event
    October 15, 2018
    Report Date
    April 30, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/78 YEARS OLD. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. LEADLESS PERMANENT PACING: A SINGLE CENTRE AUSTRALIAN EXPERIENCE HEART LUNG AND CIRCULATION 2019; 28(11):1677-1682. 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 LEADLESS PACEMAKER (LP). THE AUTHORS DESCRIBED CASES WHERE IMPLANTATION FAILED IN ONE PATIENT DUE TO INADEQUATE SENSING (POOR R WAVE), IN ONE PATIENT, THE LP DISLODGED ACUTELY FOLLOWING RELEASE OF THE TETHER AND LODGED IN THE LEFT PULMONARY ARTERY. THE DEVICE WAS SUCCESSFULLY RETRIEVED AND TWO DAYS LATER A LP WAS IMPLANTED SUCCESSFULLY WITHOUT COMPLICATIONS, AND ONE PATIENT DEVELOPED SIGNIFICANT PLEURITIC CHEST PAIN POST PROCEDURE. AN ECHOCARDIOGRAM SHOWED NO EVIDENCE OF A PERICARDIAL EFFUSION. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH SIMPLE ANALGESIA AND THE SYMPTOMS RESOLVED SPONTANEOUSLY WITH NO SEQUELAE. THE DISPOSITION OF THE DEVICES ASSOCIATED WITH THE FIRST TWO EVENTS LISTED ABOVE IS UNKNOWN AT THIS TIME. 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
    477423 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC, INC. MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization