BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

    MDR report key: 21951541 · Received May 2, 2025

    Report

    Report Number
    MW5169838
    Event Type
    Injury
    Date Received
    May 2, 2025
    Report Date
    April 21, 2025
    Manufacturer
    SORIN BIOMEDICAL/ SORIN CRM SAS
    Product Code
    MRM
    Adverse Event
    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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WITH A RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES. TECHNICAL SERVICES (TS) REVIEWED AND FOUND INTERMITTENT HIGH OUT OF RANGE RIGHT VENTRICULAR PACING IMPEDANCES OVER THE LAST YEAR. NO NOISE OR SIGNAL ARTIFACT MONITOR EPISODES WERE OBSERVED. THE FIELD REPRESENTATIVE WAS UNABLE TO INDUCE ANY NOISE OR PACING IMPEDANCE CHANGES WITH POCKET MANIPULATION OR ISOMETRICS. TS RECOMMENDED THE CRT-D BE REPLACED. SUBSEQUENTLY, THIS CRT-D WAS EXPLANTED. ANOTHER CRT-D WAS IMPLANTED TO COMPLETE THE PROCEDURE. THIS RV LEAD REMAINS IN SERVICE. 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
    1895311 DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN BIOMEDICAL/ SORIN CRM SAS 2CR-6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown