BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 21855458 · Received April 17, 2025

    Report

    Report Number
    2124215-2025-24358
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526597305
    PMA / PMN Number
    P110042/S077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT CONCLUSION WAS SELECTED FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SHORTLY AFTER AN IMPLANT PROCEDURE, AN HEALTH CARE PROFESSIONAL (HCP) TOOK AN X-RAY OF THIS NEWLY IMPLANTED ELECTRODE AND NOTICED IS WAS NOT POSITIONED IN AN OPTIMAL IMPLANT LOCATION TO PROPERLY CAPTURE AND SENSE THE HEART. ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED AND THE ELECTRODE WAS REPOSITIONED AND CONTINUES TO REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SHORTLY AFTER AN IMPLANT PROCEDURE, AN HEALTH CARE PROFESSIONAL (HCP) TOOK AN X-RAY OF THIS NEWLY IMPLANTED ELECTRODE AND NOTICED IS WAS NOT POSITIONED IN AN OPTIMAL IMPLANT LOCATION TO PROPERLY CAPTURE AND SENSE THE HEART. ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED AND THE ELECTRODE WAS REPOSITIONED AND CONTINUES TO REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32580 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 3501 275484 00802526597305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R