BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 12083979 · Received June 29, 2021

    Report

    Report Number
    2182208-2021-02626
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    January 1, 2019
    Report Date
    June 29, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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: THE CLINICAL APPLICATION AND FOLLOW-UP ANALYSIS OF LEADLESS TRANSCATHETER PACING SYSTEM. CHINESE JOURNAL OF CARDIAC PACING AND ELECTROPHYSIOLOGY. 2019. 33(6):515-517. DOI: 10.13333/J.CNKI.CJCPE.2019.06.009. 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 THIS LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE ARTICLE REPORTS ONE PATIENT WHO EXPERIENCED AN ARTERIOVENOUS (AV) FISTULA DURING THE PROCEDURE AND HAD POSTOPERATIVE SURGERY TO REPAIR BLOOD VESSELS. THE STATUS/DISPOSITION OF THE DEVICE IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980802 MICRA INTRODUCER, CATHETER DYB MEDTRONIC, INC. MI2355A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention