BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL SOLEX 7

    MDR report key: 11929772 · Received June 2, 2021

    Report

    Report Number
    MW5101675
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    March 17, 2020
    Report Date
    May 30, 2021
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OF WOMEN SUFFERED OUT OF HOSPITAL CARDIAC ARREST DUE TO AN ST-ELEVATION MYOCARDIAL INFARCTION. COMPLICATED BY PERMANENT THIRD-DEGREE AV-BLOCK. THE PATIENT UNDERWENT THERAPEUTIC HYPOTHERMIA FOR 24 HOURS WITH A ZOLL® THERMOGARD XP VIA A SOLEX 7® (9.3FRENCH, LENGTH 20 CM) CATHETER. DUE TO RECURRING AV-BLOCK A DUAL CHAMBER PACEMAKER WAS IMPLANTED WHEN TEMPORARY PACEMAKER WAS PULLED THE RIGHT ATRIAL LEAD WAS ALSO EXTRACTED DUE TO THE ATRIAL LEAD BEING FED THROUGH THE MESH OF THE COOLING CATHETER ON IMPLANTATION. THE RIGHT ATRIAL LEAD WAS REVISED THE FOLLOWING DAY. THERE WERE NO PERCEIVABLE SUBSEQUENT ADVERSE EFFECTS TO THE PATIENT. SPECIAL ATTENTION NEEDS TO BE PAYED WHEN IMPLANTING PERMANENT PACEMAKES IN PATIENTS WITH INDWELLING COOLING CATHETERS SINCE THE LEADS CAN BE FED THROUGH THE COOLING LOOPS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822864 ZOLL SOLEX 7 SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING NCX ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention