BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 17524904 · Received August 12, 2023

    Report

    Report Number
    MW5131846
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 17, 2020
    Manufacturer
    SORIN BIOMEDICAL INC
    Product Code
    MRM
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD PACING THRESHOLD INCREASED. THE LEAD IS PART OF AN ADVISORY, THEREFORE, THE DECISION WAS MADE TO EXPLANT AND REPLACE THIS RV LEAD. THIS LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. 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
    2117976 RV LEAD DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN BIOMEDICAL INC 2CR6

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown