BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

    MDR report key: 19374533 · Received May 21, 2024

    Report

    Report Number
    MW5155229
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Report Date
    April 1, 2024
    Manufacturer
    ELA / SORIN CRM SAS
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SHORT V-V¿S AND TWOS. 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
    1994412 DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM ELA / SORIN CRM SAS ISOLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown