BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 12927482 · Received December 3, 2021

    Report

    Report Number
    2182208-2021-04744
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    January 1, 2021
    Report Date
    December 3, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: REMOTE MONITORING IN A PATIENT WITH MULTIPLE LEADLESS PACEMAKERS. JOURNAL OF ARRHYTHMIA. 2021. 37:259¿260. DOI: 10.1002/JOA3.12495. . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE ARTICLE REPORTS A PATIENT WITH A LEADLESS IPG WHICH EXHIBITED AN INCREASE IN THRESHOLD. NO INTERVENTION WAS PERFORMED AND IT REMAINED IN USE. NO 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
    1826816 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC, INC. MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female