BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE DEVICE

    MDR report key: 21214625 · Received January 23, 2025

    Report

    Report Number
    2124215-2025-03079
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    January 1, 2012
    Report Date
    January 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LACHARITE-ROBERGE, ANNE-SOPHIE, ET AL. (2024). INFLAMMATORY BIOMARKERS AS PREDICTORS OF SYSTEMIC VS ISOLATED POCKET INFECTION IN PATIENTS UNDERGOING TRANSVENOUS LEAD EXTRACTION. HEART RHYTHM O2, VOL 5, NO 5, (B)(6) 2024. HTTPS://DOI.ORG/10.1016/J.HROO.2024.04.007.

    Description of Event or Problem · 0

    IT WAS REPORTED PER ARTICLE OF INTEREST LITERATURE REVIEW THAT THE AUTHORS AIMED TO DETERMINE IF INFLAMMATORY BIOMARKERS COULD HELP CLINICIANS IN THE CHALLENGING DIAGNOSIS OF CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) ISOLATED POCKET INFECTION. THEY PERFORMED A RETROSPECTIVE ANALYSIS OF ALL PATIENTS UNDERGOING TRANSVENOUS LEAD EXTRACTION FOR CIED INFECTION AT THE UNIVERSITY OF CALIFORNIA SAN DIEGO BETWEEN 2012 AND 2022 (156 PATIENTS). DATA WERE OBTAINED FROM THE ELECTRONIC MEDICAL RECORD (EMR) AND INCLUDED PATIENT DEMOGRAPHIC, CLINICAL, ECHOCARDIOGRAPHIC, AND DEVICE CHARACTERISTICS SUCH AS DEVICE TYPE, LEAD TYPE, NUMBER OF GENERATOR REPLACEMENTS, AND INITIAL INDICATION FOR IMPLANTATION. IN THE SYSTEMIC INFECTION GROUP, 50 SUBJECTS HAD POSITIVE BLOOD CULTURES FOR INFECTIOUS PATHOGENS, AND IN THE ISOLATED POCKET INFECTION GROUP, 18 PATIENTS HAD POSITIVE BLOOD CULTURES. VEGETATIONS WERE FOUND ON 43 DEVICE SYSTEMS IN THE SYSTEMIC INFECTION GROUP. SUBJECTS IN THE ISOLATED POCKET INFECTION GROUP HAD THE FOLLOWING SIGNS AND SYMPTOMS DOCUMENTED IN THE EMR: WARMTH, ERYTHEMA, FEVER, EROSION, DRAINAGE, SWELLING, AND PAIN. IN TOTAL, 66 OF 68 PATIENTS WITH ISOLATED POCKET INFECTIONS WERE FOUND TO HAVE A POSITIVE DEVICE OR POCKET TISSUE CULTURE FOR INFECTIOUS PATHOGEN. FINALLY, 25 PERCENT OF PATIENTS WITH ISOLATED POCKET INFECTION HAD POSITIVE LEAD CULTURES. BOSTON SCIENTIFIC LEADS REPRESENTED 21 OF THE 88 SYSTEMIC INFECTION LEADS, AND 10 OF THE 68 ISOLATED POCKET INFECTIONS. BOSTON SCIENTIFIC LEADS REPRESENTED 52 OF 281 IN THE CONTROL GROUP EXTRACTED FOR NONINFECTIOUS ETIOLOGIES SUCH AS LEAD FRACTURE, LEAD PERFORATION, DEVICE MALFUNCTION, SEVERE CHRONIC PAIN CAUSED BY THE DEVICE, OR NEED FOR SYSTEM UPGRADE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921694 IMPLANTABLE DEVICE DXY BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R