BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 19324389 · Received May 14, 2024

    Report

    Report Number
    MW5154920
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    October 17, 2023
    Report Date
    March 1, 2024
    Manufacturer
    ELA MEDICAL / 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

    TWOS, SHORT V-V TWOS ON VES LAST MONTH AND ADJUSTED THE RV SENSITIVITY TO 0.45MV. NO FURTHER TWOS WAS SEEN WITH ARM MANIPULATIONS AFTER THIS CHANGE. THERE HAS ALSO BEEN A SIGNIFICANT INCREASE IN SHORT V-V INTERVALS OF 12015X SINCE (B)(6) 2023 (11385X SINCE 17/10/23) AND THEN 3698X BETWEEN (B)(6) 2024. 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
    2520648 RV LEAD DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM ELA MEDICAL / SORIN CRM SAS ELA ISOLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown