BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 6007437 · Received October 6, 2016

    Report

    Report Number
    9612164-2016-01052
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 22, 2016
    Report Date
    August 2, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED AND REMAINS IN USE. THE PERICARDIAL EFFUSION RESOLVED FOUR DAYS LATER. THE PATIENT IS A PARTICIPANT IN THE (B)(6) REGISTRY (B)(6)). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED AFTER FIVE DAYS NO PERICARDIAL EFFUSION WAS PRESENT IN THE ECHOCARDIOGRAPHY. CLINICAL STUDY NAME CHANGED TO POST APPROVAL NETWORK CARDIOVASCULAR GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658890 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L