BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 9530954 · Received December 30, 2019

    Report

    Report Number
    2182208-2019-02365
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    June 8, 2018
    Report Date
    December 30, 2019
    Manufacturer
    MEDTRONIC, INC.
    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

    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 FEMALE/(B)(6) YEARS OLD. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THE PMA NUMBER FOR THIS REPORT IS LISTED AS P150033 REFERENCED ARTICLE: FEASIBILITY AND LONG-TERM EFFECTIVENESS OF A NON-APICAL MICRA PACEMAKER IMPLANTATION IN A REFERRAL CENTRE FOR LEAD EXTRACTION EUROPACE. 2019; 21(1):114-120. 10.1093/EUROPACE/EUY116. 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 LEADLESS PACEMAKERS. THE AUTHORS DISCUSSED NINE CASES OF HIGH PACING THRESHOLDS AT THE TIME OF IMPLANTATION WITH STABILIZATION AT FOLLOW UP. THERE WERE ALSO THREE CASES OF ELEVATED PACING THRESHOLDS AT THE TIME OF FOLLOW UP. THE DEVICES REMAIN IN USE. 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
    1326593 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC, INC. MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR