BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE Q-TRAK SUBCUTANEOUS ELECTRODE

    MDR report key: 19505882 · Received June 10, 2024

    Report

    Report Number
    2124215-2024-35356
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    February 1, 2015
    Report Date
    June 10, 2024
    Manufacturer
    OSCOR INC
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE REPORT WILL BE UPDATED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FROM FEBRUARY 2015 TO OCTOBER 2023, 192 PATIENTS WERE IMPLANTED WITH A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AT THIS FACILITY. OF THOSE FOUR PATIENTS, MOVED AND WERE LOST TO FOLLOW-UP. OF THE REMAINING 188 PATIENT'S, 28 EXPERIENCED PREMATURE BATTERY DEPLETION AND NEEDED EARLY REPLACEMENT WHILE TWO PATIENT'S EXPERIENCED ELECTRODE FRACTURES. OF THESE 30 PATIENTS, TWO EXPERIENCED EXTRACTIONS OF THE S-ICD DUE TO INFECTION. SPECIFIC MODEL AND SERIAL NUMBER INFORMATION WAS NOT PROVIDED. COPY OF LAZZERI, MIRCO, ET AL. (2023). "UNANTICIPATED SUBCUTANEOUS ICD END-OF-SERVICE DUE TO PREMATURE BATTERY DEPLETION AND OCCURRENCE OF LEAD FRACTURE: A SINGLE CENTRE EXPERIENCE." INTERNATIONAL JOURNAL OF CARDIOLOGY HTTPS://DOI.ORG/10.1016/J.IJCARD.2023.131687.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802309 THE Q-TRAK SUBCUTANEOUS ELECTRODE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS OSCOR INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R