BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAINLAB ELEMENTS 6.0;ELEMENTS IMAGE FUSION;ELEMENTS IMAGE FUSION ANGIO;ELEME

    MDR report key: 19864749 · Received July 29, 2024

    Report

    Report Number
    MW5157801
    Event Type
    Injury
    Date Received
    July 29, 2024
    Report Date
    July 26, 2024
    Manufacturer
    BRAINLAB AG
    Product Code
    QIH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MALPOSITION OF THE LEAD RESULTING IN LEAD EDEMA WAS REPORTED. THE CAUSE IS BELIEVED TO BE DUE TO INCORRECT PLANNING OF THE SOFTWARE (BRAINLAB) OR THE FRAME SYSTEM (RM). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281419 BRAINLAB ELEMENTS 6.0;ELEMENTS IMAGE FUSION;ELEMENTS IMAGE FUSION ANGIO;ELEME AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE QIH BRAINLAB AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown