BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 8805075 · Received July 18, 2019

    Report

    Report Number
    2124215-2019-13836
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    April 13, 2019
    Report Date
    July 18, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE CAME TO THE HOSPITAL DUE TO MULTIPLE SHOCKS FROM THE SUBCUTANEOUS ICD (PATIENT ALSO HAD A CRT-P DEVICE). DURING AN EVALUATION, IT WAS CONCLUDED THAT THE SHOCK WAS DELIVERED DUE TO 2 TO 1 CONDUCTED, ATRIAL FIBRILLATION. FURTHERMORE, THE DELIVERED SHOCK INDUCED A VENTRICULAR FIBRILLATION WHICH WAS INITIALLY UNDERSENSED; HOWEVER ULTIMATELY A SHOCK WAS DELIVERED AND A NORMAL SINUS RATE ESTABLISHED. THE PHYSICIAN ELECTED TO EXPLANT THE SICD (AS WELL AS THE CRT-P) AND UPGRADE THE PATIENT TO A CRT-D SYSTEM. THIS DECISION WAS NOT ONLY DUE TO THE INAPPROPRIATE SICD THERAPY BUT ALSO DUE TO A POCKET EROSION CONDITION. NO ALLEGATIONS/EVIDENCE OF CRT-P MALFUNCTION. THE EXPLANTED SICD DEVICE IS NOT EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597834 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 208757 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening