BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 19660953 · Received July 1, 2024

    Report

    Report Number
    MW5156954
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Report Date
    May 23, 2024
    Manufacturer
    SORIN CRM SAS
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE OBTAINED WITH THIS RIGHT VENTRICULAR (RV) LEAD. CONNECTIONS WERE TESTED SEVERAL TIMES, BUT THE ISSUE PERSISTED. GIVEN THE LONGEVITY OF THE RV LEAD, THE PHYSICIAN OPTED TO SURGICALLY ABANDON IT AND REPLACE IT. NO 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
    473886 RV LEAD DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN CRM SAS 2CR-6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown