BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR RIGHT ATRIAL (RA)

    MDR report key: 21282968 · Received January 31, 2025

    Report

    Report Number
    MW5165462
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    January 20, 2025
    Report Date
    January 28, 2025
    Manufacturer
    SORIN CRM SAS
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 2/13/2025 FOR REPORT MW5165462 TO UPDATE MANUFACTURER AND PROCODE TO LWS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET EROSION ON THE SITE OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE. AN ECHOCARDIOGRAM AND TEE WERE PERFORMED WHICH SHOWED PRESENCE OF VEGETATION ON THE RIGHT VENTRICULAR LEAD. THE LEADS HAD NOT ERODED THROUGH THE SKIN AND DID NOT SHOW SIGNS OF AN INFECTION. THE PATIENT DID NOT EXPERIENCE ANY FEVER OR CHILLS AND APPEARED TO BE FEELING WELL. THE ICD SYSTEM WAS FUNCTIONING WELL. ON (B)(6) 2025, THE ENTIRE ICD SYSTEM INCLUDING RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE EXTRACTED SUCCESSFULLY. THE ICD SYSTEM WAS DISCARDED BY THE LAB STAFF. THERE WERE NO ALLEGATIONS AGAINST THE ICD SYSTEM. A NEW SYSTEM WAS IMPLANTED ON THE PATIENT¿S RIGHT SIDE. NO NEW RA LEAD WAS IMPLANTED. THE PATIENT HAS CHRONIC ATRIAL FIBRILLATION (AF) AND DID NOT REQUIRE ONE. THE PATIENT¿S CONDITION WAS STABLE THROUGHOUT THE EVENT. NO FURTHER INTERVENTION WAS PLANNED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT MW5165463.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128085 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR RIGHT ATRIAL (RA) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS SORIN CRM SAS TILDA (RA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown