BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 19992988 · Received August 15, 2024

    Report

    Report Number
    2124215-2024-50832
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    August 18, 2023
    Report Date
    August 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED FROM REVIEW OF JOURNAL ARTICLE: MICHAEL M., ET AL. (2024). "INTRA-ABDOMINAL HEMORRHAGE TRIGGERING INAPPROPRIATE THERAPY FROM A SUBCUTANEOUS DEFIBRILLATOR." JACC: CASE REPORTS, VOL. 29, 2024. FEBRUARY 7, 2024: 102167 HTTPS://DOI.ORG/10.1016/J.JACCAS.2023.102167. IT WAS REPORTED THAT THIS 63-YEAR-OLD MAN WAS IMPLANTED WITH A BOSTON SCIENTIFIC TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM FOR PRIMARY PREVENTION OF SUDDEN CARDIAC DEATH IN THE SETTING OF REDUCED EJECTION FRACTION, HEART FAILURE AND OTHER PATIENT CO-MORBIDITIES. ONE OF THE IMPLANTED TRANSVENOUS LEADS SUSTAINED A FRACTURE AND THE PATIENT THEN ELECTED FOR IMPLANT OF A BOSTON SCIENTIFIC SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM. THE PATIENT EXPERIENCED A MASSIVE INTRA-ABDOMINAL HEMATOMA NOT RELATED TO THE SICD. HOWEVER, THE HEMATOMA ALTERED THE S-ICD SENSING VECTOR RESULTING IN AUTOMATIC DEACTIVATION OF THE SMART PASS FILTER AND SUBSEQUENT T-WAVE OVERSENSING (TWOS) AND SEVERAL INAPPROPRIATE SHOCKS. A MAGNET WAS PLACED OVER THE DEVICE TO PREVENT ADDITIONAL INAPPROPRIATE THERAPY DURING DRAINAGE OF THE HEMATOMA. FOLLOWING TREATMENT, NEW SENSING VECTORS WERE OBTAINED, AND SMART PASS WAS REACTIVATED, AND NO ADDITIONAL TWOS OCCURRED. DEVICE INTERROGATION THREE MONTHS POST DISCHARGE SHOWED GOOD R-WAVE SENSING AND NO FURTHER INAPPROPRIATE SHOCKS. THE PATIENT RECOVERED WELL FROM HIS PROLONGED HOSPITAL ADMISSION. EFFORTS TO OBTAIN THE SERIAL NUMBER OF THE SICD WERE UNSUCCESSFUL. THE SYSTEM REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163525 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A209

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O| H